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

NCT ID: NCT01170299

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-01-31

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.

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.

Conditions

Anal Cancer; Bladder Cancer; Cervical Cancer; Colorectal Cancer; Fallopian Tube Cancer; Gastrointestinal Complications; Ovarian Cancer; Radiation Toxicity; Sarcoma

Keywords

radiation toxicity; gastrointestinal complications; cervical cancer; fallopian tube cancer; ovarian epithelial cancer; ovarian germ cell tumor; ovarian sarcoma; ovarian stromal cancer; uterine sarcoma; bladder cancer; colon cancer; rectal cancer; anal cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

laboratory biomarker analysis

Intervention Type: OTHER

gastrointestinal complications management/prevention

Intervention Type: PROCEDURE

management of therapy complications

Intervention Type: PROCEDURE

selective external radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

Peter R. Blake, MD

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Jervoise Andreyev, MD

Role:

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden - London

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CDR0000681693

Identifier Type: REGISTRY

Identifier Source: secondary_id

RM-CCR-3142

Identifier Type: -

Identifier Source: secondary_id

EU-21053

Identifier Type: -

Identifier Source: secondary_id

RM-FIBRE-STUDY

Identifier Type: -

Identifier Source: org_study_id