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

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01170299

Collaborator

(none)

177

Enrollment

Location

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Anal Cancer Bladder Cancer Cervical Cancer Colorectal Cancer Fallopian Tube Cancer Gastrointestinal Complications Ovarian Cancer Radiation Toxicity Sarcoma	Dietary Supplement: dietary intervention Other: laboratory biomarker analysis Procedure: gastrointestinal complications management/prevention Procedure: management of therapy complications Radiation: selective external radiation therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

177 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jan 1, 2014

Outcome Measures

Primary Outcome Measures

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

Incidence of toxicity, defined using the Bristol Stool Chart []
Costs for symptom management []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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