Status:
COMPLETED
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
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Anal Cancer
Bladder Cancer
Eligibility:
All Genders
Up to 120 years
Phase:
NA
Brief 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 cause...
Detailed Description
OBJECTIVES: Primary * To compare the efficacy of a high- vs low-fiber intervention in preventing bowel toxicity in patients receiving radical pelvic radiotherapy treatment for gynecological, urologi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01170299
Start Date
October 1 2009
End Date
January 1 2014
Last Update
November 1 2016
Active Locations (1)
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1
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ