Investigating the effectiveness of vitamin E in reducing the incidence of chronic neurotoxicity caused by oxaliplatin in patients with colon cancer undergoing adjuvant chemotherapy
Determining the effectiveness of vitamin E drug in reducing cases of chronic neurotoxicity caused by oxaliplatin drug
Design
Clinical trial with control group, with parallel groups, double-blind, randomized. The rand function of Excel software was used for randomization.
Settings and conduct
The study will be conducted in Hazrat Rasool Akram Hospital, Iran University of Medical Sciences. Colon cancer is diagnosed using a biopsy. Neuropathy caused by chemotherapy is defined as the frequency of occurrence of different severities of neurotoxicity throughout the treatment period, the severity of which will be determined based on NCI-CTCAE_ver3 criteria. The study is double-blind, and patients and researchers investigating neuropathy symptoms will be unaware of the grouping.
Participants/Inclusion and exclusion criteria
Entry requirements: Any patient with colon cancer referred to the hospital
Conditions of non-entry: None
Intervention groups
Intervention group: one hundred and eighty doses daily of vitamin E 400 mg. Control group: one hundred and eighty doses daily of placebo.
Main outcome variables
Reducing the occurrence of chronic neurotoxicity caused by chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180313039085N3
Registration date:2023-02-08, 1401/11/19
Registration timing:prospective
Last update:2023-02-08, 1401/11/19
Update count:0
Registration date
2023-02-08, 1401/11/19
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6683 0007
Email address
tramim@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of vitamin E in reducing the incidence of chronic neurotoxicity caused by oxaliplatin in patients with colon cancer undergoing adjuvant chemotherapy
Public title
Investigating the effectiveness of vitamin E drug in reducing the incidence of chronic neurotoxicity caused by oxaliplatin drug
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Colon cancer patients are candidates for adjuvant chemotherapy
Exclusion criteria:
Patients' unwillingness to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessors will be blinded to study group allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine
Street address
School of Medicine, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.IUMS.FMD.REC.1400.077
Health conditions studied
1
Description of health condition studied
Drug-induced neurotoxicity
ICD-10 code
62.0
ICD-10 code description
Drug-induced neurotoxicity
Primary outcomes
1
Description
Neurotoxicity
Timepoint
1, 2, 3, 4, 5 and 6 months after the start of the study
Method of measurement
NCI-CTCAE-ver3 criterion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral vitamin E soft gelatin capsule with a dose of 400 international units, one daily for 180 days, is manufactured by Porateb Gostar Iranian pharmaceutical factory.
Category
Prevention
2
Description
Control group: Soft gelatin capsule without any active ingredient, one daily for 180 days, manufactured by Porateb Gostar Iranian Pharmaceuticals.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasoole Akram Hospital
Full name of responsible person
Tayeb Ramim
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 0000
Email
tayebramim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Kiwani
Street address
Hemmat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?