Evaluation of the effect of selenium supplemention on cancer-related fatigue in outpatient cancer patients and comparison of it with placebo effect in control group
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Protocol summary
Clinical trial with control group and parallel multi-blind groups randomized with random number table
A clinical trial with 70 patients, featuring a control group, parallel groups, and a triple-blind randomized design using a random number table.
ClinicalA clinical trial with 70 patients, featuring a control group, parallel groups, and parallel multia triple-blind groups randomized withdesign using a random number table.
کارآزمایی بالینی دارای گروه کنترل با گروه های موازی چند سویه کور تصادفی شده با جدول اعداد تصادفی
کارآزمایی بالینی با 70 بیمار دارای گروه کنترل با گروه های موازی سه سویه کور تصادفی شده با جدول اعداد تصادفی
کارآزمایی بالینی با 70 بیمار دارای گروه کنترل با گروه های موازی چندسه سویه کور تصادفی شده با جدول اعداد تصادفی
در زمینه بررسی میزان تاثیر مداخله فارماکولوژیک برضعف ناشی از سرطان در کلینیکهای شیمی درمانی وابسته به دانشگاه علوم پزشکی اصفهان .کورسازی گروه ها برای بیماران کلینیسین ومحقق وفرد تحلیل کننده داده ها.
در زمینه بررسی میزان تاثیر مداخله فارماکولوژیک بر ضعف ناشی از سرطان در کلینیکهای شیمی درمانی وابسته به دانشگاه علوم پزشکی اصفهان. کورسازی گروه ها برای بیماران کلینیسین و محقق و فرد تحلیل کننده داده ها.
در زمینه بررسی میزان تاثیر مداخله فارماکولوژیک برضعفبر ضعف ناشی از سرطان در کلینیکهای شیمی درمانی وابسته به دانشگاه علوم پزشکی اصفهان.کورسازی گروه ها برای بیماران کلینیسین ومحقق وفردو محقق و فرد تحلیل کننده داده ها.
Inclusion criteria were 30 to 60 years of age and the presence of cancer-induced fatigue during chemotherapy
Inclusion criteria were 18 to 80 years of age and the presence of cancer-induced fatigue during chemotherapy
Inclusion criteria were 3018 to 6080 years of age and the presence of cancer-induced fatigue during chemotherapy
شرایط ورود به مطالعه سن 30 تا 60 سال و وجود ضعف ناشی از سرطان در حین شیمی درمانی بوده است
شرایط ورود به مطالعه سن 18 تا 80 سال و وجود ضعف ناشی از سرطان در حین شیمی درمانی بوده است
شرایط ورود به مطالعه سن 3018 تا 6080 سال و وجود ضعف ناشی از سرطان در حین شیمی درمانی بوده است
Selenium supplementation in intervention group and placebo administration in control group
Seleniumplus supplementation in intervention group and placebo administration in control group
SeleniumSeleniumplus supplementation in intervention group and placebo administration in control group
مصرف مکمل سلنیوم در گروه مداخله و تجویز دارونما در گروه کنترل
مصرف مکمل سلنیوم پلاس در گروه مداخله و تجویز دارونما در گروه کنترل
مصرف مکمل سلنیوم پلاس در گروه مداخله و تجویز دارونما در گروه کنترل
پیامد اصلی عبارت است از بهبود پارامترهای مختلف مربوط به ضعف شامل خستگی فیزیکی و..در بیماران
پیامد اصلی عبارت است از بهبود پارامترهای مختلف مربوط به ضعف شامل خستگی فیزیکی و در بیماران
پیامد اصلی عبارت است از بهبود پارامترهای مختلف مربوط به ضعف شامل خستگی فیزیکی و..درو در بیماران
General information
30
18
3018
60
80
6080
Double blinded
Triple blinded
doubltripl
2022-08-23, 1401/06/01
2024-10-22, 1403/08/01
20222024-0810-2322 00:00:00
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Subject: Request for Clinical Trial Information Update
Dear Sir/Madam,
I would like to request the following changes to the registered information of the clinical trial. The reasons for these changes are as follows:
Participant Age Range:
Please update the participant age range from "30-60 years" to "18-80 years."
Reason: This change aims to broaden the scope of the study and achieve more comprehensive results by including a more diverse age group.
Duration of Supplementation:
Please adjust the supplementation duration from "6 weeks" to "4 weeks."
Reason: This change is due to the shorter chemotherapy intervals for patients, making a 4-week supplementation period more accessible.
Type of Supplement:
In the original registration, only "selenium" was mentioned. However, the placebo was prepared with vitamins A, C, and E. If this adjustment had not been made, the control group would have been deprived of treatment, which is against ethical standards.
Currently, the treatment group is receiving "Selenium Plus," while the control group is receiving "Selenium Plus without Selenium." This ensures that both groups are in similar conditions, with the only difference being the presence or absence of selenium.
To enhance the credibility of the study, a triple-blind method will be implemented. In this approach, neither the participants, researchers, nor analysts will know the type of treatment being administered, which helps to reduce bias and increase the validity of the results.
Thank you for your attention and cooperation.
Subject: Request for Clinical Trial Information Update Dear Sir/Madam, I would like to request the following changes to the registered information of the clinical trial. The reasons for these changes are as follows: Participant Age Range: Please update the participant age range from "30-60 years" to "18-80 years." Reason: This change aims to broaden the scope of the study and achieve more comprehensive results by including a more diverse age group. Duration of Supplementation: Please adjust the supplementation duration from "6 weeks" to "4 weeks." Reason: This change is due to the shorter chemotherapy intervals for patients, making a 4-week supplementation period more accessible. Type of Supplement: In the original registration, only "selenium" was mentioned. However, the placebo was prepared with vitamins A, C, and E. If this adjustment had not been made, the control group would have been deprived of treatment, which is against ethical standards. Currently, the treatment group is receiving "Selenium Plus," while the control group is receiving "Selenium Plus without Selenium." This ensures that both groups are in similar conditions, with the only difference being the presence or absence of selenium. To enhance the credibility of the study, a triple-blind method will be implemented. In this approach, neither the participants, researchers, nor analysts will know the type of treatment being administered, which helps to reduce bias and increase the validity of the results. Thank you for your attention and cooperation.
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احتراماً، خواهشمند است تغییرات زیر در اطلاعات ثبتشده کارآزمایی بالینی اعمال گردد. دلایل این تغییرات نیز به شرح زیر ارائه میشود:
سن شرکتکنندگان:
محدوده سنی شرکتکنندگان از "30 تا 60 سال" به "18 تا 80 سال" تغییر یابد.
دلیل تغییر: هدف از این تغییر، افزایش دامنه بررسی و دستیابی به نتایج گستردهتر است که شامل گروههای سنی متنوعتری میشود.
مدت زمان مصرف مکمل:
مدت زمان مکملدهی از "6 هفته" به "4 هفته" تغییر یابد.
دلیل تغییر: این تغییر به دلیل مراجعه بیماران جهت شیمیدرمانی در بازههای زمانی کوتاهتر است که دسترسی به مکمل در مدت 4 هفته را تسهیل میکند.
نوع مکمل مصرفی:
در ثبت اولیه به استفاده از "سلنیوم" اشاره شده است. در حالی که دارونما به همراه ویتامینهای A، C، و E ساخته شده است. اگر این کار انجام نمیشد، گروه شاهد از درمان محروم میماند که این امر خلاف اصول اخلاقی است.
در حال حاضر، گروه درمان "سلنیوم پلاس" دریافت کرده است و گروه شاهد "سلنیوم پلاس بدون سلنیوم" دریافت کردهاند. این ترکیب باعث شده که هم گروه شاهد و هم گروه درمان شرایط مشابهی داشته باشند و تنها تفاوت در دریافت سلنیوم باشد.
جهت اعتباربخشی بیشتر مطالعه، از روش سهسو کور استفاده میشود. در این روش، شرکتکنندگان، پژوهشگران و تحلیلگران از نوع درمان بیاطلاع هستند که این موضوع به کاهش سوگیری و افزایش اعتبار نتایج کمک میکند.
با تشکر از توجه و همکاری شما
احتراماً، خواهشمند است تغییرات زیر در اطلاعات ثبتشده کارآزمایی بالینی اعمال گردد. دلایل این تغییرات نیز به شرح زیر ارائه میشود: سن شرکتکنندگان: محدوده سنی شرکتکنندگان از "30 تا 60 سال" به "18 تا 80 سال" تغییر یابد. دلیل تغییر: هدف از این تغییر، افزایش دامنه بررسی و دستیابی به نتایج گستردهتر است که شامل گروههای سنی متنوعتری میشود. مدت زمان مصرف مکمل: مدت زمان مکملدهی از "6 هفته" به "4 هفته" تغییر یابد. دلیل تغییر: این تغییر به دلیل مراجعه بیماران جهت شیمیدرمانی در بازههای زمانی کوتاهتر است که دسترسی به مکمل در مدت 4 هفته را تسهیل میکند. نوع مکمل مصرفی: در ثبت اولیه به استفاده از "سلنیوم" اشاره شده است. در حالی که دارونما به همراه ویتامینهای A، C، و E ساخته شده است. اگر این کار انجام نمیشد، گروه شاهد از درمان محروم میماند که این امر خلاف اصول اخلاقی است. در حال حاضر، گروه درمان "سلنیوم پلاس" دریافت کرده است و گروه شاهد "سلنیوم پلاس بدون سلنیوم" دریافت کردهاند. این ترکیب باعث شده که هم گروه شاهد و هم گروه درمان شرایط مشابهی داشته باشند و تنها تفاوت در دریافت سلنیوم باشد. جهت اعتباربخشی بیشتر مطالعه، از روش سهسو کور استفاده میشود. در این روش، شرکتکنندگان، پژوهشگران و تحلیلگران از نوع درمان بیاطلاع هستند که این موضوع به کاهش سوگیری و افزایش اعتبار نتایج کمک میکند. با تشکر از توجه و همکاری شما
30 to 60 years of age
To be able to read and write
Definitive diagnosis of cancer which requires chemotherapy and has been confirmed with pathology findings and authenticated by an oncology subspecialist
Not having another treatment regimen that has healing effect on fatigue
To have cancer-related fatigue and score of 40 and above in fatigue questionnaire
To tolerate oral medication
To cooperate and agree with the study
18 to 80 years of age
To be able to read and write
Definitive diagnosis of cancer which requires chemotherapy and has been confirmed with pathology findings and authenticated by an oncology subspecialist
Not having another treatment regimen that has healing effect on fatigue
To have cancer-related fatigue and score of 40 and above in fatigue questionnaire
To tolerate oral medication
To cooperate and agree with the study
3018 to 6080 years of age To be able to read and write Definitive diagnosis of cancer which requires chemotherapy and has been confirmed with pathology findings and authenticated by an oncology subspecialist Not having another treatment regimen that has healing effect on fatigue To have cancer-related fatigue and score of 40 and above in fatigue questionnaire To tolerate oral medication To cooperate and agree with the study
سنین 30 تا 60 سال
داشتن سواد خواندن و نوشتن
تشخیص قطعی کانسر با تایید پاتولوژی و فوق تخصص انکولوژی که نیازمند شیمی درمانی باشد
عدم مصرف رژیم درمانی دیگری که اثر بهبودی بخش بر روی خستگی داشته باشد
دشتن ضعف ناشی از سرطان و امتیاز 40 و بالاتر در پرسشنامهی خستگی
توانایی دریافت داروی خوراکی
رضایت به انجام مطالعه و همکاری با آن
سنین 18 تا 80 سال
داشتن سواد خواندن و نوشتن
تشخیص قطعی کانسر با تایید پاتولوژی و فوق تخصص انکولوژی که نیازمند شیمی درمانی باشد
عدم مصرف رژیم درمانی دیگری که اثر بهبودی بخش بر روی خستگی داشته باشد
دشتن ضعف ناشی از سرطان و امتیاز 40 و بالاتر در پرسشنامهی خستگی
توانایی دریافت داروی خوراکی
رضایت به انجام مطالعه و همکاری با آن
سنین 3018 تا 6080 سال داشتن سواد خواندن و نوشتن تشخیص قطعی کانسر با تایید پاتولوژی و فوق تخصص انکولوژی که نیازمند شیمی درمانی باشد عدم مصرف رژیم درمانی دیگری که اثر بهبودی بخش بر روی خستگی داشته باشد دشتن ضعف ناشی از سرطان و امتیاز 40 و بالاتر در پرسشنامهی خستگی توانایی دریافت داروی خوراکی رضایت به انجام مطالعه و همکاری با آن
Randomization is done by simple randomization method and generating random values between zero and one in SPSS software. Random values less than or equal to 0.5 and greater than 0.5 are assigned to group A and B respectively. Then an independent individual from research team, encodes 70 envelopes (based on the codes obtained from mentioned randomization method), so a list of codes is provided. In the envelope, based on the mentioned method, either of "new treatment" or "placebo" options will be written and according to the order of eligible patients, the envelope will be given to the patients in the clinic to deliver it to an oncologist. Based on patients' grouping, the therapist provides necessary prescriptions and advices for each patient. In the meantime, the researcher remains unaware of the group to which each patients belongs.
Group Allocation and Coding:
In this clinical trial, the drugs (Selenium Plus and Selenium Plus without Selenium) were divided and coded into two groups, "A" and "B," by a pharmacology professor acting as the supervisor. This supervisor is also blinded to the contents of each group to prevent any potential bias.
Administration of the Drugs:
Neither the participants nor the researchers know which group receives which treatment. As such, the patients are unaware whether they are receiving Selenium Plus or the placebo (Selenium Plus without Selenium), and the doctors administering the treatment are similarly blinded to the type of drug being given.
Data Analysis:
Upon completion of the study and data collection, the statistical analysis is carried out by analysts who are also unaware of which group received the actual drug and which received the placebo. This ensures that the statistical results are free from bias.
Final Unblinding:
After the statistical analysis is completed, the pharmacist supervisor, who holds the group codes, reveals the information. At this stage, it is disclosed which group received Selenium Plus and which received Selenium Plus without Selenium.
RandomizationGroup Allocation and Coding: In this clinical trial, the drugs (Selenium Plus and Selenium Plus without Selenium) were divided and coded into two groups, "A" and "B," by a pharmacology professor acting as the supervisor. This supervisor is done by simple randomization method and generating random values between zero and one in SPSS software. Random values less than or equal to 0.5 and greater than 0.5 are assigned to group A and B respectively. Then an independent individual from research team, encodes 70 envelopes (based on the codes obtained from mentioned randomization method), so a list of codes is provided. In the envelope, based on the mentioned method, either of "new treatment" or "placebo" options will be written and accordingalso blinded to the ordercontents of eligible patientseach group to prevent any potential bias. Administration of the Drugs: Neither the participants nor the researchers know which group receives which treatment. As such, the envelope will be givenpatients are unaware whether they are receiving Selenium Plus or the placebo (Selenium Plus without Selenium), and the doctors administering the treatment are similarly blinded to the patients intype of drug being given. Data Analysis: Upon completion of the clinic to deliver it to an oncologist. Based on patients' groupingstudy and data collection, the therapist provides necessary prescriptions and advices for each patient. In the meantime, the researcher remainsstatistical analysis is carried out by analysts who are also unaware of which group received the actual drug and which received the placebo. This ensures that the statistical results are free from bias. Final Unblinding: After the statistical analysis is completed, the pharmacist supervisor, who holds the group tocodes, reveals the information. At this stage, it is disclosed which each patients belongsgroup received Selenium Plus and which received Selenium Plus without Selenium.
تصادفی سازی با روش تصادفی ساده و تولید مقادیر تصادفی بین صفر و یک در نرم افزار spss انجام می شود. مقادیر کمتر یا مساوی 0.5 به گروه A و مقادیر بزرگتر از 0.5 به گروه B تخصیص داده می شوند. سپس یک فرد مستقل از تیم تحقیق 70 پاکت را(بر اساس کدهای به دست آمده در روش تصادفی سازی فوقالذکر) کدگذاری نموده و بنابراین لیستی از کدها تهیه میشود. درون هر پاکت بر اساس روش فوق، یکی از گزینههای «درمان جدید» یا «پلاسبو» نوشته میشود و به ترتیب ورود بیماران واجد شرایط، در کلینیک به بیماران داده می شود تا آن را به انکولوژیست بدهند. پزشک درمانگر بر اساس گروه بندی انجام شده برای هر بیمار تجویز و توصیه های لازم را ارایه می دهد. ضمنا محقق از اینکه هر بیمار در کدام گروه قرار گرفته بدون اطلاع باقی میماند.
تقسیم و کدگذاری گروهها:
در این کارآزمایی، داروها (سلنیوم پلاس و سلنیوم پلاس بدون سلنیوم) توسط یکی از اساتید فارماکولوژی، که به عنوان ناظر عمل میکند، به دو گروه "A" و "B" تقسیم و کدگذاری شدهاند. این ناظر خود از محتوای هر گروه بیاطلاع است تا از هرگونه سوگیری جلوگیری شود.
دادن دارو به شرکتکنندگان:
شرکتکنندگان و پژوهشگران نیز از نوع دارویی که به هر گروه داده شده است، آگاه نیستند. بدین ترتیب، بیماران نمیدانند که داروی آنها سلنیوم پلاس یا دارونمای بدون سلنیوم است، و پزشکان نیز در هنگام ارائه دارو به بیماران، نمیدانند که چه دارویی داده میشود.
تحلیل دادهها:
پس از تکمیل مطالعه و جمعآوری دادهها، اطلاعات آماری توسط تحلیلگران بدون اطلاع از اینکه کدام گروه داروی واقعی و کدام گروه دارونما را دریافت کردهاند، تحلیل میشود. این تضمین میکند که نتایج آماری بدون سوگیری به دست میآیند.
رمزگشایی نهایی:
در نهایت، پس از تحلیل آماری، داروساز ناظر که کدهای گروهها را در اختیار دارد، اطلاعات را فاش میکند و مشخص میشود که کدام گروه "سلنیوم پلاس" و کدام گروه "سلنیوم پلاس بدون سلنیوم" را دریافت کرده است.
تصادفی سازی با روش تصادفی سادهتقسیم و تولید مقادیر تصادفی بین صفرکدگذاری گروهها: در این کارآزمایی، داروها (سلنیوم پلاس و یک در نرم افزار spss انجامسلنیوم پلاس بدون سلنیوم) توسط یکی از اساتید فارماکولوژی، که به عنوان ناظر عمل میکند، به دو گروه "A" و "B" تقسیم و کدگذاری شدهاند. این ناظر خود از محتوای هر گروه بیاطلاع است تا از هرگونه سوگیری جلوگیری شود. مقادیر کمتردادن دارو به شرکتکنندگان: شرکتکنندگان و پژوهشگران نیز از نوع دارویی که به هر گروه داده شده است، آگاه نیستند. بدین ترتیب، بیماران نمیدانند که داروی آنها سلنیوم پلاس یا مساوی 0.5دارونمای بدون سلنیوم است، و پزشکان نیز در هنگام ارائه دارو به گروه A و مقادیر بزرگتر از 0.5 به گروه B تخصیصبیماران، نمیدانند که چه دارویی داده می شوند. سپس یک فرد مستقل از تیم تحقیق 70 پاکت را(بر اساس کدهای به دست آمده در روش تصادفی سازی فوقالذکر) کدگذاری نموده و بنابراین لیستی از کدها تهیه میشود. درون هر پاکت بر اساس روش فوق، یکیتحلیل دادهها: پس از گزینهتکمیل مطالعه و جمعهای «درمان جدید» یا «پلاسبو» نوشتهآوری دادهها، اطلاعات آماری توسط تحلیلگران بدون اطلاع از اینکه کدام گروه داروی واقعی و کدام گروه دارونما را دریافت کردهاند، تحلیل میشود. این تضمین میکند که نتایج آماری بدون سوگیری به دست میآیند. رمزگشایی نهایی: در نهایت، پس از تحلیل آماری، داروساز ناظر که کدهای گروهها را در اختیار دارد، اطلاعات را فاش میکند و مشخص میشود و به ترتیب ورود بیماران واجد شرایط، در کلینیک به بیماران داده می شود تا آن را به انکولوژیست بدهند. پزشک درمانگر بر اساس گروه بندی انجام شده برای هر بیمار تجویز و توصیه های لازم را ارایه می دهد. ضمنا محقق از اینکه هر بیمار درکه کدام گروه قرار گرفته"سلنیوم پلاس" و کدام گروه "سلنیوم پلاس بدون اطلاع باقی میماندسلنیوم" را دریافت کرده است.
Primary outcomes
#1
ضعف مرتبط باسرطان
ضعف مرتبط با سرطان
ضعف مرتبط باسرطانبا سرطان
Zero, 3 weeks, 6 weeks
Zero, 2 weeks, 4 weeks
Zero, 32 weeks, 64 weeks
صفر و3 هفته و6 هفته
صفر و 2 هفته و 4 هفته
صفر و3و 2 هفته و6و 4 هفته
Intervention groups
#1
Intervention group: In this group, patients take 200 ug selenium capsules under the brand name of Selenium Alpha manufactured by Alpha Vitamin Laboratories, Inc once daily for 3 weeks and then fill in the fatigue questionnaire. After filling out the questionnare patients take the mentioned supplement for another 3 weeks (a total of 6 weeks of supplemention is performed). Finally, patients fill in the questionnaire once more and the results are analyzed using SPSS software version 10.
Intervention Group: In this group, patients will take one 200 µg capsule of Selenium Plus once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the capsule for an additional 2 weeks, totaling 4 weeks of treatment. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 10.
Intervention groupGroup: In this group, patients will take one 200 ug selenium capsules under the brand nameµg capsule of Selenium Alpha manufactured by Alpha Vitamin Laboratories, IncPlus once daily for 32 weeks and then fill in, after which they will complete the fatigue questionnaire. After filling outThey will then continue taking the questionnare patients take the mentioned supplementcapsule for another 3an additional 2 weeks (a total of 6, totaling 4 weeks of supplemention is performed)treatment. Finally, patients fill inthey will complete the questionnaire once more and the. The results arewill be analyzed using SPSS software version 10.
گروه مداخله: در این گروه بیماران روزانه در 1نوبت هر بار 1کپسول 200ug از کپسول سلنیوم با نام تجاری سلنیوم آلفا متعلق به شرکت داروسازی آلفا ویتامین را به مدت3 هفته مصرف و سپس پرسشنامه خستگی را پر میکنند. مجددا آن را به مدت 3 هفته دیگر یعنی جمعا 6 هفته مصرف می نمایند.در نهایت باز هم یکبار دیگر پرسشنامه را تکمیل میکنند و نتایج بانرم افزار اس پی اس اس 10 آنالیز میشود
گروه مداخله: در این گروه بیماران روزانه در یک نوبت هر بار یک کپسول 200میکروگرم از کپسول سلنیوم پلاس را به مدت2 هفته مصرف و سپس پرسشنامه خستگی را پر میکنند. مجددا آن را به مدت 2هفته دیگر یعنی جمعا 4 هفته مصرف می نمایند.در نهایت باز هم یکبار دیگر پرسشنامه را تکمیل میکنند و نتایج بانرم افزار اس پی اس اس 10 آنالیز میشود.
گروه مداخله: در این گروه بیماران روزانه در 1نوبتیک نوبت هر بار 1کپسول 200ugیک کپسول 200میکروگرم از کپسول سلنیوم با نام تجاری سلنیوم آلفا متعلق به شرکت داروسازی آلفا ویتامینپلاس را به مدت3مدت2 هفته مصرف و سپس پرسشنامه خستگی را پر میکنند. مجددا آن را به مدت 3 هفته2هفته دیگر یعنی جمعا 64 هفته مصرف می نمایند.در نهایت باز هم یکبار دیگر پرسشنامه را تکمیل میکنند و نتایج بانرم افزار اس پی اس اس 10 آنالیز میشود.
#2
Control group: In this group, patients take 1 capsule of placebo once daily for 3 weeks and then fill in the questionnaire of fatigue. After an interval of 1 week, patients take 1 capsule of placebo once daily for another 3 weeks (a total of 6 weeks of supplemention is performed). Finally patients fill in the questionnaire once more and results are analyzed using SPSS software version 10.
Control Group: In this group, patients will take a placebo once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the placebo for an additional 2 weeks, totaling 4 weeks. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 10.
Control groupGroup: In this group, patients will take 1 capsule ofa placebo once daily for 32 weeks and, after which they will complete the fatigue questionnaire. They will then fill incontinue taking the questionnaire of fatigue. Afterplacebo for an interval of 1 weekadditional 2 weeks, patients take 1 capsule of placebo once daily for another 3totaling 4 weeks (a total of 6 weeks of supplemention is performed). Finally patients fill in, they will complete the questionnaire once more and. The results arewill be analyzed using SPSS software version 10.
گروه کنترل:در این گروه بیماران پلاسبو را روزانه در یک نوبت به مدت 3 هفته مصرف و پس از پر کردن پرسشنامه خستگی مجددا به مدت 3 هفته دیگر (جمعا 6 هفته) مصرف می نمایند.در نهایت باز هم یکبار دیگر پرسشنامه را تکمیل میکنند و نتایج بانرم افزار اس پی اس اس 10 مورد تحلیل قرار میگیرند.
گروه کنترل: در این گروه، بیماران پلاسبو را، روزانه در یک نوبت به مدت 2 هفته مصرف و پس از پر کردن پرسشنامه خستگی مجددا به مدت 2 هفته دیگر (جمعا4 هفته) مصرف می نمایند.در نهایت باز هم یکبار دیگر پرسشنامه را تکمیل میکنند و نتایج بانرم افزار اس پی اس اس 10 مورد تحلیل قرار میگیرند.
گروه کنترل:در این گروه، بیماران پلاسبو را، روزانه در یک نوبت به مدت 32 هفته مصرف و پس از پر کردن پرسشنامه خستگی مجددا به مدت 32 هفته دیگر (جمعا 6جمعا4 هفته) مصرف می نمایند.در نهایت باز هم یکبار دیگر پرسشنامه را تکمیل میکنند و نتایج بانرم افزار اس پی اس اس 10 مورد تحلیل قرار میگیرند.
Recruitment centers
#1
Name of recruitment center - English: Alzahra clinics
Name of recruitment center - Persian: کلینیک الزهرا(شیمی درمانی)
Full name of responsible person - English: کلینیک الزهرا(شیمی درمانی)
Full name of responsible person - Persian: علی حاجی غلامی
Street address - English: Sheikh Mofid Street
Street address - Persian: خیابان شیخ مفید
City - English: esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8163743787
Phone: +98 31 3776 2744
Fax:
Email: Ali_hajigholami@yahoo.com
Web page address:
Name of recruitment center - English: Alzahra clinics
Name of recruitment center - Persian: کلینیک الزهرا(شیمی درمانی)
Full name of responsible person - English: Alihajigholami
Full name of responsible person - Persian: علی حاجی غلامی
Street address - English: Sheikh Mofid St.
Street address - Persian: خیابان شیخ مفید
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8163743787
Phone: +98 31 3776 2744
Fax:
Email: Ali_hajigholami@yahoo.com
Web page address:
Name of recruitment center - English: Alzahra clinics Name of recruitment center - Persian: کلینیک الزهرا(شیمی درمانی) Full name of responsible person - English: کلینیک الزهرا(شیمی درمانی)Alihajigholami Full name of responsible person - Persian: علی حاجی غلامی Street address - English: Sheikh Mofid StreetSt. Street address - Persian: خیابان شیخ مفید City - English: esfahanIsfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8163743787 Phone: +98 31 3776 2744 Fax: Email: Ali_hajigholami@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mrs Shaghayegh Haghjooye Javaanmard
Full name of responsible person - Persian: معاونت پژوهشی خانم دکتر شقایق حق جوی جوانمرد
Street address - English: Hezar Jarib Street-Vice Chancellery of Research and Technology
Street address - Persian: خیابان هزارجریب دانشکده پزشکی معاونت پژوهشی
City - English: esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 8134
Fax:
Email: Ali_hajigholami@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mrs Shaghayegh Haghjooye Javaanmard
Full name of responsible person - Persian: معاونت پژوهشی خانم دکتر شقایق حق جوی جوانمرد
Street address - English: Vice Chancellery for Research and Technology, Hezar Jarib St
Street address - Persian: خیابان هزارجریب دانشکده پزشکی معاونت پژوهشی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 8134
Fax:
Email: Ali_hajigholami@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mrs Shaghayegh Haghjooye Javaanmard Full name of responsible person - Persian: معاونت پژوهشی خانم دکتر شقایق حق جوی جوانمرد Street address - English: Hezar Jarib Street-Vice Chancellery offor Research and Technology, Hezar Jarib St Street address - Persian: خیابان هزارجریب دانشکده پزشکی معاونت پژوهشی City - English: esfahanIsfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3792 8134 Fax: Email: Ali_hajigholami@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Alireza Mansouri
Full name of responsible person - Persian: علیرضا منصوری
Position - English: Medical student
Position - Persian: دانشجوی پزشکی
Latest degree: a_level
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Dolphin 2 complex, Bagh Ziar St, Sohrevardi Blvd, Isfahan, Iran
Street address - Persian: خیابان سهروردی-باغ زیار -مجتمع دلفین 2
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8177773095
Phone: +98 31 3776 2744
Mobile: +98 913 823 5586
Fax:
Email: alireza.mansory@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Alireza Mansouri
Full name of responsible person - Persian: علیرضا منصوری
Position - English: Medical student
Position - Persian: دانشجوی پزشکی
Latest degree: a_level
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Dolphin 2 complex Bagh Ziar St Sohrevardi Blvd Isfahan Iran
Street address - Persian: خیابان سهروردی، باغ زیار، مجتمع دلفین 2
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8177773095
Phone: +98 31 3776 2744
Mobile: +98 913 823 5586
Fax:
Email: alireza.mansory@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Alireza Mansouri Full name of responsible person - Persian: علیرضا منصوری Position - English: Medical student Position - Persian: دانشجوی پزشکی Latest degree: a_level Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Dolphin 2 complex, Bagh Ziar St, Sohrevardi Blvd, Isfahan, Iran Street address - Persian: خیابان سهروردی-، باغ زیار -، مجتمع دلفین 2 City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8177773095 Phone: +98 31 3776 2744 Mobile: +98 913 823 5586 Fax: Email: alireza.mansory@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Houriye Ansari
Full name of responsible person - Persian: خانم دکتر حوریه انصاری
Position - English: Social Medicine Specialist
Position - Persian: متخصص پزشکی اجتماعی
Latest degree: specialist
Area of specialty/work: 29
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Social and Family Medicine
Street address - Persian: گروه پزشکی اجتماعی و خانواده
City - English: esfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 8123
Mobile: +98 913 125 0248
Fax:
Email: houri_|ansari@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Houriye Ansari
Full name of responsible person - Persian: خانم دکتر حوریه انصاری
Position - English: Social Medicine Specialist
Position - Persian: متخصص پزشکی اجتماعی
Latest degree: specialist
Area of specialty/work: 29
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hezar jarib
Street address - Persian: هزار جریب
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 8123
Mobile: +98 913 125 0248
Fax:
Email: houri_|ansari@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr Houriye Ansari Full name of responsible person - Persian: خانم دکتر حوریه انصاری Position - English: Social Medicine Specialist Position - Persian: متخصص پزشکی اجتماعی Latest degree: specialist Area of specialty/work: 29 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Social and Family MedicineHezar jarib Street address - Persian: گروه پزشکی اجتماعی و خانوادههزار جریب City - English: esfahanEsfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3792 8123 Mobile: +98 913 125 0248 Fax: Email: houri_|ansari@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Alireza Mansouri
Full name of responsible person - Persian: علیرضامنصوری
Position - English: Medical student
Position - Persian: دانشجو پزشکی
Latest degree: a_level
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sohrevardi St.
Street address - Persian: خیابان سهروردی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8177773095
Phone: +98 31 3776 2744
Mobile: +98 913 823 5586
Fax:
Email: alireza.mansory@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Alireza Mansouri
Full name of responsible person - Persian: علیرضا منصوری
Position - English: Medical student
Position - Persian: دانشجو پزشکی
Latest degree: a_level
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sohrevardi St.
Street address - Persian: خیابان سهروردی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8177773095
Phone: +98 31 3776 2744
Mobile: +98 913 823 5586
Fax:
Email: alireza.mansory@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Alireza Mansouri Full name of responsible person - Persian: علیرضامنصوریعلیرضا منصوری Position - English: Medical student Position - Persian: دانشجو پزشکی Latest degree: a_level Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Sohrevardi St. Street address - Persian: خیابان سهروردی City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8177773095 Phone: +98 31 3776 2744 Mobile: +98 913 823 5586 Fax: Email: alireza.mansory@gmail.com Web page address:
Protocol summary
Study aim
The aim of this study was to evaluate the effect of selenium supplementation on cancer-related fatigue in cancer patients undergoing chemotherapy and to compare it with the placebo effect.
Design
A clinical trial with 70 patients, featuring a control group, parallel groups, and a triple-blind randomized design using a random number table.
Settings and conduct
Based on previous studies on the effects of pharmacological intervention on cancer-related fatigue in chemotherapy clinics affiliated to Isfahan University of Medical Sciences. Blinding the groups of clinicians, researchers and data analysts.
Participants/Inclusion and exclusion criteria
Inclusion criteria were 18 to 80 years of age and the presence of cancer-induced fatigue during chemotherapy
Intervention groups
Seleniumplus supplementation in intervention group and placebo administration in control group
Main outcome variables
The main outcome is the improvement of various parameters related to fatigue including physical weakness, etc. in patients.
General information
Reason for update
Subject: Request for Clinical Trial Information Update
Dear Sir/Madam,
I would like to request the following changes to the registered information of the clinical trial. The reasons for these changes are as follows:
Participant Age Range:
Please update the participant age range from "30-60 years" to "18-80 years."
Reason: This change aims to broaden the scope of the study and achieve more comprehensive results by including a more diverse age group.
Duration of Supplementation:
Please adjust the supplementation duration from "6 weeks" to "4 weeks."
Reason: This change is due to the shorter chemotherapy intervals for patients, making a 4-week supplementation period more accessible.
Type of Supplement:
In the original registration, only "selenium" was mentioned. However, the placebo was prepared with vitamins A, C, and E. If this adjustment had not been made, the control group would have been deprived of treatment, which is against ethical standards.
Currently, the treatment group is receiving "Selenium Plus," while the control group is receiving "Selenium Plus without Selenium." This ensures that both groups are in similar conditions, with the only difference being the presence or absence of selenium.
To enhance the credibility of the study, a triple-blind method will be implemented. In this approach, neither the participants, researchers, nor analysts will know the type of treatment being administered, which helps to reduce bias and increase the validity of the results.
Thank you for your attention and cooperation.
Acronym
IRCT registration information
IRCT registration number:IRCT20210825052293N1
Registration date:2021-10-03, 1400/07/11
Registration timing:prospective
Last update:2025-02-19, 1403/12/01
Update count:2
Registration date
2021-10-03, 1400/07/11
Registrant information
Name
alireza mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 2744
Email address
alireza.mansory@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of selenium supplemention on cancer-related fatigue in outpatient cancer patients and comparison of it with placebo effect in control group
Public title
The effect of selenium on cancer related-fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 80 years of age
To be able to read and write
Definitive diagnosis of cancer which requires chemotherapy and has been confirmed with pathology findings and authenticated by an oncology subspecialist
Not having another treatment regimen that has healing effect on fatigue
To have cancer-related fatigue and score of 40 and above in fatigue questionnaire
To tolerate oral medication
To cooperate and agree with the study
Exclusion criteria:
Patients with known depression undergoing treatment
Having anemia
Having a disease that prevents patient from continuing participation in study
When more than 20% of the questionnaire has not been completed
Pregnancy and lactation
Renal failure
Taking medications such as baloxavir, marboxil, deferiprone, cabotegravir, bisphosphonate derivatives, bictegravir, dolutegravir, eltrombopag, trientine, raltegravir, penicillamine, elvitegravir
Known allergy to selenium
Hypothyroidism
Skin cancer and individulas at high risk for developing squamous cell carcinoma
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Group Allocation and Coding:
In this clinical trial, the drugs (Selenium Plus and Selenium Plus without Selenium) were divided and coded into two groups, "A" and "B," by a pharmacology professor acting as the supervisor. This supervisor is also blinded to the contents of each group to prevent any potential bias.
Administration of the Drugs:
Neither the participants nor the researchers know which group receives which treatment. As such, the patients are unaware whether they are receiving Selenium Plus or the placebo (Selenium Plus without Selenium), and the doctors administering the treatment are similarly blinded to the type of drug being given.
Data Analysis:
Upon completion of the study and data collection, the statistical analysis is carried out by analysts who are also unaware of which group received the actual drug and which received the placebo. This ensures that the statistical results are free from bias.
Final Unblinding:
After the statistical analysis is completed, the pharmacist supervisor, who holds the group codes, reveals the information. At this stage, it is disclosed which group received Selenium Plus and which received Selenium Plus without Selenium.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The secretary introduced the patients to the oncologist using randomized grouping and the oncologist provided treatments for each patient based on their group. The researcher, in cooperation with the oncologist, supervised the patient's use of the drug. Data available from questionnaires completed by the patients, were analyzed by a statistician specialist with respect to the confidentiality of the grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Isfahan University of Medical Sciences
Intervention Group: In this group, patients will take one 200 µg capsule of Selenium Plus once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the capsule for an additional 2 weeks, totaling 4 weeks of treatment. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 10.
Category
Treatment - Drugs
2
Description
Control Group: In this group, patients will take a placebo once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the placebo for an additional 2 weeks, totaling 4 weeks. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 10.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra clinics
Full name of responsible person
Alihajigholami
Street address
Sheikh Mofid St.
City
Isfahan
Province
Isfehan
Postal code
8163743787
Phone
+98 31 3776 2744
Email
Ali_hajigholami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mrs Shaghayegh Haghjooye Javaanmard
Street address
Vice Chancellery for Research and Technology, Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
Ali_hajigholami@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Mansouri
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Dolphin 2 complex Bagh Ziar St Sohrevardi Blvd Isfahan Iran
City
Isfahan
Province
Isfehan
Postal code
8177773095
Phone
+98 31 3776 2744
Email
alireza.mansory@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Houriye Ansari
Position
Social Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Hezar jarib
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8123
Email
houri_|ansari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Mansouri
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Sohrevardi St.
City
Isfahan
Province
Isfehan
Postal code
8177773095
Phone
+98 31 3776 2744
Email
alireza.mansory@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data in the study except for personal data can be shared.
When the data will become available and for how long
The start of the access period is 6 months after the results are printed.
To whom data/document is available
At the current stage,the results will be available to researchers at university institutes.
Under which criteria data/document could be used
In terms of data analysis and analysis for academic researchers and use in later studies.
From where data/document is obtainable
School of social medicine,Isfahan Ali_hajigholami@yahoo.com
What processes are involved for a request to access data/document
By submitting a written request to the director of the Social Medicine School, Isfahan