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 neuropathy in cancer patients undergoing chemotherapy with paclitaxel and carboplatin
Design
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.
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 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.
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
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N6
Registration date:2021-07-29, 1400/05/07
Registration timing:registered_while_recruiting
Last update:2021-07-29, 1400/05/07
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 carboplatin-induced neuropathy in cancer patients: a randomized double-bind controlled clinical trial
Public title
The effect of curcumin on the prevention of paclitaxel and carboplatin-induced neuropathy in cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50 years
Initiation of the treatment with paclitaxel and carboplatin 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 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
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
thics committee of ُ Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
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, 10, 20, 30, 40 science starting chemotherapy
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 40 days. Patients are evaluated for neuropathy on days 1, 10, 20, 30 and 40
Category
Prevention
2
Description
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
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