Health Condition 1: C61- Malignant neoplasm of prostate Health Condition 2: C51-C58- Malignant neoplasms of female genital organs
Conditions
Interventions
Intervention1: Capsule Racecadotril: Cap Racecadotril 100mg TDS + Placebo tablet TDS
Will be assessing the grade (CTCAE) of acute radiation enteritis after 48 hours on day 3
Control Intervention1: Tab
Sponsors
IMRF
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactAbhijith P B
JIPMER
Outcome results
None listed