Evaluation of the Effect of Melatonin Drug in Decreasing Fatigue Caused by Adjuvant Radiotherapy and Chemotherapy in Women with Breast Cancer: A Clinical Trial
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Protocol summary
Female breast cancer patients with stages I to III who during the first half of 1397 will be referred to Mahdieh Hospital and Besat Hospital for receiving adjuvant radiation therapy and chemotherapy, using a simple randomization method, and with a full explanation of the study and Written consent will be entered into the study. with a randomized block design patients will be treated with melatonin or placebo( control group). For blinding medicine and placebo are put in similar envelopes in the opaque package, which have been numbered. Blocking and preparation of envelopes is done by a non-involved person in data sampling and analysis, and thus the health care provider, the data collector, the participant and the person analyzing the data, are not aware of the intervention type received, and Who is located in each group
Female breast cancer patients with stages I to III who during the second half of 1397 will be referred to Mahdieh Hospital and Besat Hospital for receiving adjuvant radiation therapy and chemotherapy, using a simple randomization method, and with a full explanation of the study and Written consent will be entered into the study. with a randomized block design patients will be treated with melatonin or placebo( control group). For blinding medicine and placebo are put in similar envelopes in the opaque package, which have been numbered. Blocking and preparation of envelopes is done by a non-involved person in data sampling and analysis, and thus the health care provider, the data collector, the participant and the person analyzing the data, are not aware of the intervention type received, and Who is located in each group
Female breast cancer patients with stages I to III who during the firstsecond half of 1397 will be referred to Mahdieh Hospital and Besat Hospital for receiving adjuvant radiation therapy and chemotherapy, using a simple randomization method, and with a full explanation of the study and Written consent will be entered into the study. with a randomized block design patients will be treated with melatonin or placebo( control group). For blinding medicine and placebo are put in similar envelopes in the opaque package, which have been numbered. Blocking and preparation of envelopes is done by a non-involved person in data sampling and analysis, and thus the health care provider, the data collector, the participant and the person analyzing the data, are not aware of the intervention type received, and Who is located in each group
بیماران زن با سرطان پستان با استیج های I الی III که طی نیمه اول سال 1397 جهت درمان پرتودرمانی و شیمی درمانی ادجوانت به مرکز تشخیصی و درمانی مهدیه و بیمارستان بعثت مراجعه خواهند کرد، با استفاده از روش رندوفیزاسیون ساده انتخاب شده و با توضیح کامل مطالعه و کسب رضایت نامه کتبی وارد مطالعه می شوند. بیماران وارد شده بصورت تصادفی( بلوک تصادفی) تحت درمان با ملاتونین یا پلاسبو( گروه کنترل) قرار خواهند گرفت.به منظور کورسازی دارو و پلاسبو در پاکتهای مشابه در بسته مات که پشت سر هم شماره گذاری شده، قرار داده شده ند. بلوکبندی و آماده سازی پاکتها توسط یك فرد غیر درگیر در نمونه گیری و تجزیه و تحلیل دادهها انجام شده و بدین ترتیب مراقب سلامت، فرد جمع آوری کننده داده ها، شرکت کننده و فرد تجزیه و تحلیل کننده داده ها، از نوع مداخله دریافتی و این که هر فرد در چه گروهی قرار گرفته بود، اطلاعی ندارند
بیماران زن با سرطان پستان با استیج های I الی III که طی نیمه دوم سال 1397 جهت درمان پرتودرمانی و شیمی درمانی ادجوانت به مرکز تشخیصی و درمانی مهدیه و بیمارستان بعثت مراجعه خواهند کرد، با استفاده از روش رندوفیزاسیون ساده انتخاب شده و با توضیح کامل مطالعه و کسب رضایت نامه کتبی وارد مطالعه می شوند. بیماران وارد شده بصورت تصادفی( بلوک تصادفی) تحت درمان با ملاتونین یا پلاسبو( گروه کنترل) قرار خواهند گرفت.به منظور کورسازی دارو و پلاسبو در پاکتهای مشابه در بسته مات که پشت سر هم شماره گذاری شده، قرار داده شده ند. بلوکبندی و آماده سازی پاکتها توسط یك فرد غیر درگیر در نمونه گیری و تجزیه و تحلیل دادهها انجام شده و بدین ترتیب مراقب سلامت، فرد جمع آوری کننده داده ها، شرکت کننده و فرد تجزیه و تحلیل کننده داده ها، از نوع مداخله دریافتی و این که هر فرد در چه گروهی قرار گرفته بود، اطلاعی ندارند
بیماران زن با سرطان پستان با استیج های I الی III که طی نیمه اولدوم سال 1397 جهت درمان پرتودرمانی و شیمی درمانی ادجوانت به مرکز تشخیصی و درمانی مهدیه و بیمارستان بعثت مراجعه خواهند کرد، با استفاده از روش رندوفیزاسیون ساده انتخاب شده و با توضیح کامل مطالعه و کسب رضایت نامه کتبی وارد مطالعه می شوند. بیماران وارد شده بصورت تصادفی( بلوک تصادفی) تحت درمان با ملاتونین یا پلاسبو( گروه کنترل) قرار خواهند گرفت.به منظور کورسازی دارو و پلاسبو در پاکتهای مشابه در بسته مات که پشت سر هم شماره گذاری شده، قرار داده شده ند. بلوکبندی و آماده سازی پاکتها توسط یك فرد غیر درگیر در نمونه گیری و تجزیه و تحلیل دادهها انجام شده و بدین ترتیب مراقب سلامت، فرد جمع آوری کننده داده ها، شرکت کننده و فرد تجزیه و تحلیل کننده داده ها، از نوع مداخله دریافتی و این که هر فرد در چه گروهی قرار گرفته بود، اطلاعی ندارند
General information
2018-04-22, 1397/02/02
2018-10-07, 1397/07/15
2018-0410-2207 00:00:00
2018-09-22, 1397/06/31
2019-03-21, 1398/01/01
20182019-0903-2221 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Mahdieh Diagnostic and Treatment Center
Name of recruitment center - Persian: مرکز تشخیصی و درمانی مهدیه
Full name of responsible person - English: Abdul Azim Seddighi Pashaki
Full name of responsible person - Persian: عبدالعظیم صدیقی پاشاکی
Street address - English: Mahdieh Diagnostic and Treatment Center. , Parastar Ave., Besat Blvd.
Street address - Persian: مرکز تشخیص و درمانی مهدیه ، خیابان پرستار، بلوار بعثت
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 8138381225
Phone: +98 81 3838 0044
Fax:
Email: hmmahdiyeh@gmail.com
Web page address:
Name of recruitment center - English: Mahdieh Diagnostic and Treatment Center
Name of recruitment center - Persian: مرکز تشخیصی و درمانی مهدیه
Full name of responsible person - English: Abdulazim Sedighi Pashaki
Full name of responsible person - Persian: عبدالعظیم صدیقی پاشاکی
Street address - English: Mahdieh Diagnostic and Treatment Center, Parastar Ave., Besat Blvd.
Street address - Persian: مرکز تشخیص و درمانی مهدیه، خیابان پرستار، بلوار بعثت
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 8138381225
Phone: +98 81 3838 0044
Fax:
Email: hmmahdiyeh@gmail.com
Web page address:
Name of recruitment center - English: Mahdieh Diagnostic and Treatment Center Name of recruitment center - Persian: مرکز تشخیصی و درمانی مهدیه Full name of responsible person - English: Abdul Azim SeddighiAbdulazim Sedighi Pashaki Full name of responsible person - Persian: عبدالعظیم صدیقی پاشاکی Street address - English: Mahdieh Diagnostic and Treatment Center. , Parastar Ave., Besat Blvd. Street address - Persian: مرکز تشخیص و درمانی مهدیه، خیابان پرستار، بلوار بعثت City - English: Hamedan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 8138381225 Phone: +98 81 3838 0044 Fax: Email: hmmahdiyeh@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyyed Habibollah Musavi Bahar
Full name of responsible person - Persian: سید حبیب الله موسوی بهار
Street address - English: Hamedan University of Medical Sciences , Shahid Fahmideh Street , Hamedan
Street address - Persian: دانشگاه علوم پزشکی همدان، خیابان شهید فهمیده، همدان
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838678
Phone: +98 81 3252 0183
Fax:
Email: ICT@umsha.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Haghighi
Full name of responsible person - Persian: محمد حقیقی
Street address - English: Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
Street address - Persian: دانشگاه علوم پزشکی همدان، خیابان شهید فهمیده، همدان
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838678
Phone: +98 81 3252 0183
Fax:
Email: ICT@umsha.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyyed Habibollah Musavi BaharMohammad Haghighi Full name of responsible person - Persian: سید حبیب الله موسوی بهارمحمد حقیقی Street address - English: Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan Street address - Persian: دانشگاه علوم پزشکی همدان، خیابان شهید فهمیده، همدان City - English: Hamedan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 6517838678 Phone: +98 81 3252 0183 Fax: Email: ICT@umsha.ac.ir Web page address:
Protocol summary
Study aim
Determining the Effect of Melatonin Drug in Decresing Fatigue Caused by Adjuvant Radiation therapy and Chemotherapy in Breast Cancer Patients
Design
Phase 3 clinical trial with 64 patients with control group, community-based and pragmatic, with parallel groups, triple blinded, with a randomized block design
Settings and conduct
Female breast cancer patients with stages I to III who during the second half of 1397 will be referred to Mahdieh Hospital and Besat Hospital for receiving adjuvant radiation therapy and chemotherapy, using a simple randomization method, and with a full explanation of the study and Written consent will be entered into the study. with a randomized block design patients will be treated with melatonin or placebo( control group). For blinding medicine and placebo are put in similar envelopes in the opaque package, which have been numbered. Blocking and preparation of envelopes is done by a non-involved person in data sampling and analysis, and thus the health care provider, the data collector, the participant and the person analyzing the data, are not aware of the intervention type received, and Who is located in each group
Participants/Inclusion and exclusion criteria
Female breast cancer patients with stage I-III( according to the AJCC) who receive adjuvant chemotherapy and radiation therapy;
No Consumption of Warfarin, Methylphenidate and Hypnotics during using Melatonin, No Pregnancy or Breastfeeding
Intervention groups
Patients will be randomly treated with melatonin or placebo( control group). Oral Melatonin Drug 6 mg( 2 mg capsule 3 mg) from 3 to 7 days before the start of Adjuvant treatment will be consumed every night until the disease progression
Main outcome variables
Type of treatment;
Gender;
Age;
Fatigue severity;
The type of adjuvant treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180426039421N1
Registration date:2018-06-16, 1397/03/26
Registration timing:prospective
Last update:2018-09-11, 1397/06/20
Update count:1
Registration date
2018-06-16, 1397/03/26
Registrant information
Name
Zahra Kesht pour amlashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1076
Email address
z.keshtpour@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Melatonin Drug in Decreasing Fatigue Caused by Adjuvant Radiotherapy and Chemotherapy in Women with Breast Cancer: A Clinical Trial
Public title
Effect of Melatonin Drug in Decreasing Fatigue Caused by Radiotherapy and Chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Breast Cancer Stages I, II, III According to Pathological Reports
Patients at least 18 Years Old
Have Signed a Written Consent
Recevieng Adjuvant Chemotherapy and Radiotherapy
No Untreated Hypercalcemia
No Systolic Blood Pressure Less Than 100 mm Hg
No Warfarin Consumption
No Methylphenidate Consumption
No Sleep Pills During Melatonin Use
No TSH>5/5 or <0/5
No Pregnancy or Breastfeeding
Exclusion criteria:
Expired During Treatment
Stop Using Melatonin during Treatment
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Any number of female breast cancer patients with stage I-III( according to the AJCC system) are selected by simple randomization method and the patients are randomized (randomized block design) to receive melatonin or placebo (control group) .
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding includes:
Participants( patients)
Clinical care provider( radiotherapy-oncology physicians and chemotherapy nurses)
Researcher and evaluator of the outcome and data analyzer: (radiotherapy-oncology resident)
In order to hide allocation, medicine and placebo are put in similar envelopes in the opaque package, which have been numbered. Blocking and preparation of envelopes are performed by a non-involved person in data sampling and analysis. Thus, the clinical care provider, the data collector, the participant and the data analyst, are unaware of the type of intervention received and who is located in each group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.UMSHA.REC.1397.5
Health conditions studied
1
Description of health condition studied
Breast Cance; Cancer Related Fatigue; Melatonin
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Fatigue severity in the BFI questionnaire
Timepoint
4 weeks after last adjuvant treatment session
Method of measurement
Brief Fatigue Inventory( BFI) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral Melatonin drug 6 mg( 2 capsule of 3 mg) every night from 3 to 7 days before the start of Adjuvant treatmentwill be used until the disease progresses
Category
Rehabilitation
2
Description
Control group: The placebo will be taken every night from 3 to 7 days before the start of the adjuvant treatment until the disease progresses
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Diagnostic and Treatment Center
Full name of responsible person
Abdulazim Sedighi Pashaki
Street address
Mahdieh Diagnostic and Treatment Center, Parastar Ave., Besat Blvd.
City
Hamedan
Province
Hamadan
Postal code
8138381225
Phone
+98 81 3838 0044
Email
hmmahdiyeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3252 0183
Email
ICT@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kesht Pour Amlashi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
MRI and Radiotherapy Center of Mahdie, Parastar Ave., Besat Blvd.
City
Hamadan
Province
Hamadan
Postal code
8138381225
Phone
+98 81 3838 1076
Email
z.keshtpour@edu.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kesht Pour Amlashi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
MRI and Radiotherapy Center of Mahdie, Parastar Ave., Besat Blvd.
City
Hamadan
Province
Hamadan
Postal code
8138381225
Phone
+98 81 3838 1076
Email
z.keshtpour@edu.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kesht Pour Amlashi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
MRI and Radiotherapy Center of Mahdie, Parastar Ave., Besat Blvd.
City
Hamadan
Province
Hamadan
Postal code
8138381225
Phone
+98 81 3838 1076
Email
z.keshtpour@edu.umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available