operamide versus Racecadotril in management of Radiation Enteritis
Phase 2
Completed
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostateHealth Condition 2: C51-C58- Malignant neoplasms of female genital organs
- Registration Number
- CTRI/2020/04/024721
- Lead Sponsor
- IMRF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 162
Inclusion Criteria
Histologically proven abdominal and pelvic malignancy without metastases beyond the regional lymph nodes receiving pelvic radiation treatment developing Grade 2 or 3 acute radiation as per Common Toxicity criteria version 4.0 enteritis.
Karnofsky performance status > 60.
Absence of fever with white blood cell count of between 3,000 - 11,000/mm3
Exclusion Criteria
Patients with grade 4 acute radiation enteritis as per Common Toxicity criteria version 4.0.
Patients with blood in stools.
Uncontrolled diabetes and hypertension.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the proportion of patients with CTCAE Grade 2 and above acute radiation enteritis improving to Grade 1 or 0Timepoint: 2 days after starting the drugs in both arms.
- Secondary Outcome Measures
Name Time Method To compare the proportion of patients requiring interruption of radiation in both armsTimepoint: Uncontrolled Grade 3 or above acute radiation enteritis afetr 4 days of treatment with respective drugs.;To compare the proportion of patients who develop recurrence of Grade 2 and Grade 3 diarrhea in both arms.Timepoint: Till 2 weeks post radiation treatment;To compare the side effect profile of both the drugsTimepoint: 2 weeks post radiation treatment;To compare the time taken in hours for resolution of CTCAE Grade 2 and above diarrhea to Grade 1Timepoint: 2 days after starting the drugs in both arms.