NCT04205955

Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors

Completed Phase 2 Results posted Last updated 1 May 2024

What this trial tests

Phase 2 trial testing Best Practice in Rectal Carcinoma in 95 participants. Completed in 1 August 2023.

Timeline

10 February 2020

Primary endpoint
1 April 2023

1 August 2023

Quick facts

Lead sponsor	SWOG Cancer Research Network
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	95
Start date	10 February 2020
Primary completion	1 April 2023
Estimated completion	1 August 2023
Sites	226 locations across Guam, United States

Drugs / interventions tested

• Best Practice
• Dietary Intervention
• Message
• Quality-of-Life Assessment
• Questionnaire Administration

Conditions studied

• Rectal Carcinoma — all drugs for Rectal Carcinoma →
• Rectosigmoid Carcinoma — all drugs for Rectosigmoid Carcinoma →

Sponsor

SWOG Cancer Research Network

Who can join

18 and older, any sex, with Rectal Carcinoma or Rectosigmoid Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Bowel Function Primary · At 18 weeks after randomization

Will be measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) total score. Score range 18-90. Higher scores indicate better bowel function. Will be conducted according to a modified intention-to-treat principle. Study arm differences in BFI at 18 weeks will be assessed by a linear regression model as a function of randomization assignment, BFI baseline value, and stratification factors.

Group	Value	95% CI
Arm I (Diet Modification Coaching, Motivational Messages)	30.8	29.2 – 32.4
Arm II (Standard of Care, Motivational Messages)	29.5	27.3 – 31.7

Sponsor's own description

This phase II trial studies how a diet intervention works in improving bowel dysfunction symptoms related in colon or rectal cancer survivors. Changing a diet may be helpful in reducing the severity of bowel symptoms, including diarrhea and constipation, and improve quality of life in colon or rectal cancer survivors and help doctors learn how to help patients better in the future.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.