CompletedNot Applicable

Low-Fiber Diet or High-Fiber Diet in Preventing Bowel Side Effects in Patients Undergoing Radiation Therapy for Gynecological Cancer, Bladder Cancer, Colorectal Cancer, or Anal Cancer

United Kingdom177 participantsStarted 2009-10

Plain-language summary

RATIONALE: Fiber may lessen bowel side effects caused by radiation therapy. It is not yet known whether a high-fiber diet is more effective than a low-fiber diet in preventing bowel side effects caused by radiation therapy. PURPOSE: This randomized clinical trial is studying a high-fiber diet to see how well it works compared with a low-fiber diet in preventing bowel side effects in patients undergoing radiation therapy for gynecological cancer, bladder cancer, colorectal cancer, or anal cancer.

Who can participate

Age range120 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of gynecological, urological (bladder), colorectal, or anal malignant cancer * Scheduled to undergo a course of radical or adjuvant pelvic radiotherapy (≥ 45 Gy) * Radiotherapy regimen will be delivered in daily fractions comprising approximately ≥ 25 fractions over 5-7 weeks PATIENT CHARACTERISTICS: * No prior prescribed low-residue diet for a clear medical reason * No established wheat intolerance or celiac disease * No concurrent condition precluding oral nutritional intake PRIOR CONCURRENT THERAPY: * No gastrointestinal stent * No jejunostomy, ileostomy, or colostomy * No concurrent participation in a study with toxicity as an endpoint

What they're measuring

Change in IBDQ-B (Inflammatory Bowel Disease Questionnaire - Bowel Subset) score between baseline (i.e., Day 1 of radiotherapy treatment) and the nadir score during treatment

Trial details

NCT IDNCT01170299

SponsorRoyal Marsden NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12