Determining the effect of pregabalin drug in the treatment of neuropathy caused by oxaliplatin treatment in colorectal cancer patients with Folfox treatment regimen.
Design
This study will be conducted as a two-sided clinical trial in two intervention and control groups during the year 2023 in the hematology and oncology departments of Shahid Beheshti Hospital in Qom. A lottery method will be used to assign patients to two intervention and control groups. In order to observe blinding, the researcher and the examiner will be unaware of the type of treatment group of the patients.
The mentioned patients will be divided into two equal groups. In the first group, patients will receive pregabalin chemotherapy at a dose of 75 mg every 12 hours for one month in the first month, in addition to the main cancer treatment regimen. But in the second group of patients, they will only receive treatment with the main cancer treatment regimen drugs.
Settings and conduct
This study will be conducted as a double-blind in the hematoncology departments of ShahidBeheshti Hospital. For blinding, researcher and examiner will be unaware.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of colorectal cancer, Age over 18 years, Not using another chemotherapy regimen at the same time.
Exit criteria: Previous history of neuropathy, Diagnosis of polymyositis, Renal failure (GFR less than 50), Liver failure (liver enzymes more than 2-3 times normal), Diabetic patients.
Intervention groups
In the intervention group, in addition to the main cancer treatment regimen, patients will also receive pregabalin at a dose of 75 mg every 12 hours for one month in the first month.
Main outcome variables
The degree of neuropathy in these patients will be measured based on a 0-10 grading scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231022059806N1
Registration date:2023-11-05, 1402/08/14
Registration timing:registered_while_recruiting
Last update:2023-11-05, 1402/08/14
Update count:0
Registration date
2023-11-05, 1402/08/14
Registrant information
Name
masoud aliakbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
amirqeqe@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-29, 1402/08/07
Expected recruitment end date
2024-10-28, 1403/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pregabalin effect on treatment of Oxaliplatin-induced-neuropathy in patients with colorectal cancer with Folfox regime
Public title
pregabalin effect on Oxaliplatin-induced-neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Colorectal cancer diagnosis
Age above 18 years
Not using other chemotherapy regimen at the same time
Exclusion criteria:
Previous history of neuropathy
Diagnosis of polymyositis
Renal failure (GFR less than 50)
Liver failure (liver enzymes more than 2-3 times normal)
Diabetic patients.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
A lottery method will be used to assign patients to two intervention and control groups. In the first stage, groups are written in the form of group A, B. Then, a lottery is drawn between the two groups to determine which is the intervention group and which is the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the data analyst and the outcome assessor will be unaware of the type of group therapy of the patients.
The data in the form of questionnaires A and B will be given to the person analyzing the final data so that they are unaware of the treatment group.
The outcome evaluator is not involved in the way of dividing the patients and does not know which patients have received the intervention and will only complete the questionnaire and evaluate the outcome.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Qom University Medical Sciences
Street address
Saheli St., Qom University of Medical Sciences, Qom.
City
qom
Province
Ghoum
Postal code
3713649373
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.MUQ.REC.1402.003
Health conditions studied
1
Description of health condition studied
colorectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
Primary outcomes
1
Description
The amount of neuropathy in these patients will be measured.
Timepoint
In order to check the duration of neuropathy in these patients, this questionnaire will be completed 3 months and 6 months after the end of treatment.
Method of measurement
The amount of neuropathy in these patients will be measured based on a grading scale of 0 to 10. In assessing the severity of painful neuropathy based on this criterion: 0 indicates that the patient has no pain and 10 indicates the most pain that the patient has ever experienced.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the main cancer treatment regimen, patients will also receive pregabalin chemotherapy at a dose of 75 mg every 12 hours for one month in the first month.
Category
Treatment - Drugs
2
Description
Control group: Patients treated with the main cancer treatment regimen will only receive it.