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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200825048515N36
Enrollment
64
Registered
2021-08-06
Start date
2021-08-22
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention group: Patients are treated with atorvastatin at a dose of 40 mg daily from the beginning of radiotherapy to 3 months after treatment. Intervention 2: Control group: Patie

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSimin Hemati

Esfahan University of Medical Sciences

Hematti@med.mui.ac.ir+98 31 3235 0213

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026