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

October 31, 2016 updated by: Royal Marsden NHS Foundation Trust

A Randomized Controlled Trial to Investigate the Role of Low or High 'Fibre' Diets in Patients Undergoing Pelvic Radiotherapy - The Fibre Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, urological (bladder), colorectal, or anal malignancy.
  • To compare whether a high- or low-fiber intervention has any beneficial effect over no intervention (i.e., ad-libitum fiber consumption).
  • To examine the effect of a low- or high-fiber diet on gastrointestinal symptoms, measured using the IBDQ-B and Bristol Stool Chart, in patients receiving radical radiotherapy for pelvic malignancies.
  • To minimize any potential risk associated with change in fiber intake by using a controlled and gradual dietary-based intervention combined with dietetic advice.

Secondary

  • To examine the relationship between volume of irradiated bowel and onset of gastrointestinal symptoms as measured by the Bristol Stool Chart.
  • To measure percentage compliance with fiber prescription through validated dietetic techniques including the 7-day Food Diary using household measures and the 24-hour recall.

OUTLINE: Patients are stratified according to disease (gynecological vs gastrointestinal) and concomitant therapy (received vs not received). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (low-fiber diet): Patients are assessed by a qualified dietitian, receive written guidance, and are counseled as to how best to meet their study fiber prescription of a low-fiber diet, comprising 'not more than' 10 g of fiber per day for up to 7 weeks.
  • Arm II (high-fiber diet): Patients are assessed by a qualified dietitian, receive written guidance, and are counseled as to how best to meet their study fiber prescription of a high-fiber diet, comprising a target of between 18 and 22 g of fiber per day for up to 7 weeks.
  • Arm III (no intervention): Patients receive advice designed to ensure they maintain their normal habitual diet for up to 7 weeks.

All patients undergo radiotherapy once daily comprising approximately 25 (or more) fractions in total to be delivered for 5-7 weeks in the absence of unacceptable toxicity.

All patients are asked to complete two 7-day Food Diaries at baseline and end of radiotherapy treatment. All patients keep a daily record of stool characteristics and frequency using the Bristol Stool Chart. Patients also complete a short 1-page weekly-cost questionnaire to assess the economic impact of symptom management. Patients in arms I and II complete several additional questions regarding the costs (if any) of adhering to their fiber prescription and the palatability of the diet.

Blood and stool samples may be collected at baseline and during study therapy for biomarker analysis.

After completion of study treatment, patients are followed up for up to 1 year.

Study Type

Interventional

Enrollment (Anticipated)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden - London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
Incidence of toxicity, defined using the Bristol Stool Chart
Costs for symptom management

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Study Chair: Peter R. Blake, MD, Royal Marsden NHS Foundation Trust
  • Jervoise Andreyev, MD, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 24, 2010

First Submitted That Met QC Criteria

July 24, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM-FIBRE-STUDY
  • CDR0000681693 (Registry Identifier: PDQ (Physician Data Query))
  • RM-CCR-3142
  • EU-21053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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