The effect of atorvastatin in the prevention of gastrointestinal toxicity in patients undergoing pelvic radiotherapy

Phase 3

Recruiting

Conditions: Condition 1: Gynecological cancer. Condition 2: Urological Cancer.
Malignant neoplasm of female genital organ, unspecified
Malignant neoplasm of bladder, unspecified
C57.9
C67.9

Registration Number: IRCT20200825048515N36

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 64

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal toxicity. Timepoint: Before the intervention, during the intervention, immediately after the intervention, three months after the intervention. Method of measurement: Inflammatory Bowel Disease questionnaire-bowel(IBDQ-B).

Secondary Outcome Measures