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The effect of curcumin on the prevention of paclitaxel and platinum compounds-induced neuropathy in cancer patients: a randomized double-blinded controlled clinical trial

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History
# Registration date Revision Id
2 2022-06-29, 1401/04/08 232189
1 2021-07-29, 1400/05/07 191991
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  • Protocol summary

    The effect of curcumin on the prevention of neuropathy in cancer patients undergoing chemotherapy with paclitaxel and carboplatin
    The effect of curcumin on the prevention of neuropathy in cancer patients undergoing chemotherapy with paclitaxel and platinum compounds
    بررسی اثر کورکومین در پیشگیری از نوروپاتی در بیماران سرطانی که تحت کموتراپی با پکلی تاکسل و کربوپلاتین قرار دارند
    بررسی اثر کورکومین در پیشگیری از نوروپاتی در بیماران سرطانی که تحت کموتراپی با پکلی تاکسل و ترکیبات پلاتینیوم قرار دارند
    Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. Excel software RND() function is used for randomization. Patients are evaluated for neuropathy on days 1, 10, 20, 30, and 40.
    Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. Excel software RND() function is used for randomization. Patients are evaluated for neuropathy on days 1, 4, 7, 14, and 28.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 60 بیمار. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده می شود. بیماران در روزهای 1، 10، 20، 30 و 40 از نظر نوروپاتی مورد ارزیابی قرار می گیرند.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 70 بیمار. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده می شود. بیماران در روزهای 1، 4، 7، 14و 28 از نظر نوروپاتی مورد ارزیابی قرار می گیرند.
    Inclusion criteria: Age 20-50 years Initiation of paclitaxel and carboplatin in cancer patients Inclusion criteria: History of allergy to curcumin or turmeric Drug addiction Existence of diseases such as diabetes, alcoholism that cause neuropathy Taking drugs such as amiodarone, colchicine, isoniazid, ethambutol that cause neuropathy Taking drugs such as tricyclic antidepressants (TCA) , selective serotonin reuptake inhibitors (SSRI), especially venlafaxine, duloxetine, pregabalin, gabapentin that mask the symptoms of neuropathy.
    Inclusion criteria: Age 20-50 years Initiation of paclitaxel and platinum compounds in cancer patients Inclusion criteria: History of allergy to curcumin or turmeric Drug addiction Existence of diseases such as diabetes, alcoholism that cause neuropathy Taking drugs such as amiodarone, colchicine, isoniazid, ethambutol that cause neuropathy Taking drugs such as tricyclic antidepressants (TCA) , selective serotonin reuptake inhibitors (SSRI), especially venlafaxine, duloxetine, pregabalin, gabapentin that mask the symptoms of neuropathy.
    معیار ورود: سن 20-50سال شروع مصرف پاکلیتاکسل و کربوپلاتین دربیماران سرطانی معیار عدم ورود: سابقه حساسیت به کورکومین یا زردچوبه اعتیاد به مواد مخدر وجودبیماری هایی مثل دیابت،الکلیسم که نوروپاتی میدهند مصرف داروهایی مثل آمیودارون، کلشی سین، ایزونیازید، اتامبوتول که باعث نوروپاتی می شوند مصرف داروهایی مثل ضد افسردگی های سه حلقه ای و مهار کننده های انتخابی بازجذب سروتونین مخصوصا ونلافاکسین، دولوکستین، پرگابالین، گاباپنتین که علایم نوروپاتی را می پوشانند.
    معیار ورود: سن 20-50سال شروع مصرف پاکلیتاکسل و ترکیبات پلاتینیوم دربیماران سرطانی معیار عدم ورود: سابقه حساسیت به کورکومین یا زردچوبه اعتیاد به مواد مخدر وجودبیماری هایی مثل دیابت،الکلیسم که نوروپاتی میدهند مصرف داروهایی مثل آمیودارون، کلشی سین، ایزونیازید، اتامبوتول که باعث نوروپاتی می شوند مصرف داروهایی مثل ضد افسردگی های سه حلقه ای و مهار کننده های انتخابی بازجذب سروتونین مخصوصا ونلافاکسین، دولوکستین، پرگابالین، گاباپنتین که علایم نوروپاتی را می پوشانند.

  • General information

    18
    20
    30
    35
    empty
    A slight change in the title changes to platinum compounds instead of carboplatin Change the number of participants from 30 to 35 in each group Change the inclusion age from 18 to 20 Minor change in patient follow-up times
    empty
    تغییر جزعی در عنوان بجای کربوپلاتین به ترکیبات پلاتینیوم تغییر می یابد تغییر تعداد شرکت کننده از 30 نفر به 35 نفر در هر گروه تغییر سن ورود به مطالعه از 18 به 20 تغییر جزعی در زمانهای پی گیری بیمار
    The effect of curcumin on the prevention of paclitaxel and carboplatin-induced neuropathy in cancer patients
    The effect of curcumin on the prevention of paclitaxel and platinum compounds-induced neuropathy in cancer patients
    بررسی اثر کورکومین در پیشگیری از نوروپاتی ناشی از پاکلیتاکسل و کربوپلاتین دربیماران مبتلا به سرطان
    بررسی اثر کورکومین در پیشگیری از نوروپاتی ناشی از پاکلیتاکسل و ترکیبات پلاتینیوم دربیماران مبتلا به سرطان
    The effect of curcumin on the prevention of paclitaxel and carboplatin-induced neuropathy in cancer patients: a randomized double-bind controlled clinical trial
    The effect of curcumin on the prevention of paclitaxel and platinum compounds-induced neuropathy in cancer patients: a randomized double-blinded controlled clinical trial
    بررسی اثر کورکومین در پیشگیری از نوروپاتی ناشی از پاکلیتاکسل وکربوپلاتین دربیماران مبتلا به سرطان: یک کار آزمایی بالینی تصادفی دو سوکور
    بررسی اثر کورکومین در پیشگیری از نوروپاتی ناشی از پاکلیتاکسل و ترکیبات پلاتینیوم دربیماران مبتلا به سرطان: یک کار آزمایی بالینی تصادفی دو سوکور
    Age 20-50 years
    Initiation of the treatment with paclitaxel and carboplatin in cancer patients
    Age 20-50 years
    Initiation of the treatment with paclitaxel and platinum compounds in cancer patients
    سن 20-50 سال
    شروع درمان با پاکلیتاکسل و کاربوپلاتین در بیماران سرطانی
    سن 20-50 سال
    شروع درمان با پاکلیتاکسل و یا ترکیبات پلاتینیوم در بیماران سرطانی

  • Primary outcomes

    #1
    Days 1, 10, 20, 30, 40 science starting chemotherapy
    Days 1, 4, 7, 14, 28 science starting internention
    روزهای 10 و 20 و 30 و 40 از شروع کموتراپی
    روزهای 1 و 4 و 7 و 14 و 28 از شروع مداخله

  • Intervention groups

    #1
    Intervention group: Daily recipient of 80 mg of oral curcumin from Sina Droo Pharmaceutical Company with Sina Curcumin brand for 40 days. Patients are evaluated for neuropathy on days 1, 10, 20, 30 and 40
    Intervention group: Daily recipient of 80 mg of oral curcumin from Sina Droo Pharmaceutical Company with Sina Curcumin brand for 28 days. Patients are evaluated for neuropathy on days 1, 4, 7, 14and 28
    گروه مداخله: دریافت کننده روزانه 80 میلی گرم کورکومین خوراکی از شرکت دارویی سینا دارو با برند سیناکورکومین بمدت 40 روز. بیماران در روزهای 1، 10، 20، 30 و 40 از نظر نوروپاتی مورد ارزیابی قرار می گیرند.
    گروه مداخله: دریافت کننده روزانه 80 میلی گرم کورکومین خوراکی از شرکت دارویی سینا دارو با برند سیناکورکومین بمدت 28 روز. بیماران در روزهای 1، 4، 7، 14و 28از نظر نوروپاتی مورد ارزیابی قرار می گیرند.
    #2
    Control group: Daily recipient of one oral capsule containing starch as placebo from Pharmacy school for 40 days. Patients are evaluated for neuropathy on days 1, 10, 20, 30 and 40
    Control group: Daily recipient of one oral capsule containing starch as placebo from Pharmacy school for 28days. Patients are evaluated for neuropathy on days 1, 4, 7, 14and 28
    گروه کنترل: دریافت کننده روزانه یک عدد کپسول خوراکی حاوی نشاسته بعنوان پلاسبو بمدت 40 روز. بیماران در روزهای 1، 10، 20، 30 و 40 از نظر نوروپاتی مورد ارزیابی قرار می گیرند
    گروه کنترل: دریافت کننده روزانه یک عدد کپسول خوراکی حاوی نشاسته بعنوان پلاسبو بمدت 28روز. بیماران در روزهای 1، 4، 7، 14و 28از نظر نوروپاتی مورد ارزیابی قرار می گیرند

Protocol summary

Study aim
The effect of curcumin on the prevention of neuropathy in cancer patients undergoing chemotherapy with paclitaxel and platinum compounds
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. Excel software RND() function is used for randomization. Patients are evaluated for neuropathy on days 1, 4, 7, 14, and 28.
Settings and conduct
The study is performed on cancer patients referred to Shahid Sadoughi Hospital, Yazd, Iran, under the supervision of an oncologist. Drugs and placebo are prepared uniformly and patients receive one of the drugs or placebo based on random numbers. Neither the doctor nor the patient knows the contents of the container containing the medicine.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20-50 years Initiation of paclitaxel and platinum compounds in cancer patients Inclusion criteria: History of allergy to curcumin or turmeric Drug addiction Existence of diseases such as diabetes, alcoholism that cause neuropathy Taking drugs such as amiodarone, colchicine, isoniazid, ethambutol that cause neuropathy Taking drugs such as tricyclic antidepressants (TCA) , selective serotonin reuptake inhibitors (SSRI), especially venlafaxine, duloxetine, pregabalin, gabapentin that mask the symptoms of neuropathy.
Intervention groups
Intervention group: Daily consumption of 80 mg of oral curcumin along with standard treatment of the patient Control group: daily consumption of one placebo oral capsule along with the standard treatment of the patient
Main outcome variables
Neuropathy score based on the standard neuropathic pain questionnaire

General information

Reason for update
A slight change in the title changes to platinum compounds instead of carboplatin Change the number of participants from 30 to 35 in each group Change the inclusion age from 18 to 20 Minor change in patient follow-up times
Acronym
IRCT registration information
IRCT registration number: IRCT20191106045356N6
Registration date: 2021-07-29, 1400/05/07
Registration timing: registered_while_recruiting

Last update: 2022-07-03, 1401/04/12
Update count: 1
Registration date
2021-07-29, 1400/05/07
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin on the prevention of paclitaxel and platinum compounds-induced neuropathy in cancer patients: a randomized double-blinded controlled clinical trial
Public title
The effect of curcumin on the prevention of paclitaxel and platinum compounds-induced neuropathy in cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50 years Initiation of the treatment with paclitaxel and platinum compounds in cancer patients
Exclusion criteria:
History of allergy to curcumin or turmeric Having diseases that cause neuropathy such as diabetes or conditions such as alcoholism.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
Curcumin and placebo are uniformly divided into two groups of drug containers that are labeled A or B in terms of the shape of the drug and the container containing the drug. In such a way that the doctor and the patient do not know the type of medicine in each medicine container. Patients who meet the inclusion criteria receive one of the drugs labeled A or B based on the RND() function of Excel software and take one number daily for 42 days, and they are evaluated during and after the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medicine and placebo are placed in uniform containers and the doctor and the patient do not know the type of medicine prescribed 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 ُ Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2021-06-30, 1400/04/09
Ethics committee reference number
IR.SSU.MEDICINE.REC.1400.134

Health conditions studied

1

Description of health condition studied
Chemotherapy induced neuropathy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The neuropathy score is determined based on the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, which includes a test with 20 yes / no questions.
Timepoint
Days 1, 4, 7, 14, 28 science starting internention
Method of measurement
Patient examination and Michigan Neuropathy Screening Instrument (MNSI) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Daily recipient of 80 mg of oral curcumin from Sina Droo Pharmaceutical Company with Sina Curcumin brand for 28 days. Patients are evaluated for neuropathy on days 1, 4, 7, 14and 28
Category
Prevention

2

Description
Control group: Daily recipient of one oral capsule containing starch as placebo from Pharmacy school for 28days. Patients are evaluated for neuropathy on days 1, 4, 7, 14and 28
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Mirzaie
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
mzabihi100@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
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
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