Determination of the effect of atorvastatin in the prevention of gastrointestinal toxicity in patients undergoing pelvic radiotherapy
Design
Non-randomized, Double-blinding clinical trial, with the parallel groups, Phase 3 on 64 patients
Settings and conduct
In this non-randomized double-blind clinical trial study, 64 patients with pelvic radiotherapy indications referred to Seyyed Al-Shohada hospital in Isfahan will be included and divided into 2 groups. One group will receive atorvastatin and the other group will receive a placebo. Then the degree of gastrointestinal toxicity of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include حelvic radiotherapy indication due to gynecological, urological and lower gastrointestinal cancers, at least 18 years old, the total pelvic dose of patients during radiotherapy should be between 45-50 Gy, acceptable renal function and GFR> 60, and satisfaction to participate in the study.
Exclusion criteria include having a history of pelvic radiotherapy, having diabetes due to the possibility of intestinal disorders, having an active liver or muscle disease, having contraindications to the use of statins, having a serious physical or mental problem that prevents the completion of the course of treatment, evidence of metastasis (having a performance status score greater than 70), taking cytochrome P450 3A4 inhibitors. and withdrawal from continuing to study.
Intervention groups
Intervention group: Patients are treated with atorvastatin at a dose of 40 mg daily from the beginning of radiotherapy to 3 months after treatment.
Control group; Patients are treated with the placebo at a dose of 40 mg daily from the beginning of radiotherapy to 3 months after treatment.
Main outcome variables
Gastrointestinal toxicity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N36
Registration date:2021-08-06, 1400/05/15
Registration timing:prospective
Last update:2021-08-06, 1400/05/15
Update count:0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-22, 1400/05/31
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of the effect of atorvastatin in the prevention of gastrointestinal toxicity in patients undergoing pelvic radiotherapy
Public title
The effect of atorvastatin in the prevention of gastrointestinal toxicity in patients undergoing pelvic radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pelvic radiotherapy indication due to gynecological, urological and lower gastrointestinal cancers.
At least 18 years old.
The total pelvic dose of patients during radiotherapy should be between 45-50 Gy.
Acceptable renal function and GFR> 60
Satisfaction to participate in the study
Exclusion criteria:
Having a history of pelvic radiotherapy.
Having diabetes due to the possibility of intestinal disorders
Having an active liver or muscle disease
Having the contraindications to the use of statins
Having a serious physical or mental problem that prevents the completion of the course of treatment
Evidence of metastasis (having a performance status score greater than 70)
Taking cytochrome P450 3A4 inhibitors
Unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two drugs, atorvastatin and placebo, are prepared by the pharmacist in the same shape, color. Then these are placed in coded packages and provided to the researcher, who prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-03-02, 1399/12/12
Ethics committee reference number
IR.MUI.MED.REC.1399.1146
Health conditions studied
1
Description of health condition studied
Gynecological cancer
ICD-10 code
C57.9
ICD-10 code description
Malignant neoplasm of female genital organ, unspecified
2
Description of health condition studied
Urological Cancer
ICD-10 code
C67.9
ICD-10 code description
Malignant neoplasm of bladder, unspecified
Primary outcomes
1
Description
Gastrointestinal toxicity
Timepoint
Before the intervention, during the intervention, immediately after the intervention, three months after the intervention