Protocol summary
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Study aim
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The effect of curcumin on the prevention of neuropathy in cancer patients undergoing chemotherapy with paclitaxel and platinum compounds
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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Neuropathy score based on the standard neuropathic pain questionnaire
General information
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Reason for update
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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
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Acronym
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IRCT registration information
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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
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Registration date
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2021-07-29, 1400/05/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-22, 1400/03/01
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Expected recruitment end date
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2021-10-07, 1400/07/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of curcumin on the prevention of paclitaxel and platinum compounds-induced neuropathy in cancer patients
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
35
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-30, 1400/04/09
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Ethics committee reference number
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IR.SSU.MEDICINE.REC.1400.134
Health conditions studied
1
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Description of health condition studied
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Chemotherapy induced neuropathy
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The neuropathy score is determined based on the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, which includes a test with 20 yes / no questions.
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Timepoint
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Days 1, 4, 7, 14, 28 science starting internention
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Method of measurement
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Patient examination and Michigan Neuropathy Screening Instrument (MNSI) questionnaire
Intervention groups
1
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Description
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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
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Category
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Prevention
2
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Description
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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
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available