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
Primary Purpose
Anal Cancer, Bladder Cancer, Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
dietary intervention
laboratory biomarker analysis
gastrointestinal complications management/prevention
management of therapy complications
selective external radiation therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Anal Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Royal Marsden - London
Outcomes
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
Full Information
NCT ID
NCT01170299
First Posted
July 24, 2010
Last Updated
October 31, 2016
Sponsor
Royal Marsden NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01170299
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Marsden NHS Foundation Trust
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary intervention
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
gastrointestinal complications management/prevention
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Intervention Type
Radiation
Intervention Name(s)
selective external radiation therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of toxicity, defined using the Bristol Stool Chart
Title
Costs for symptom management
10. Eligibility
Sex
All
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter R. Blake, MD
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jervoise Andreyev, MD
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Facility Information:
Facility Name
Royal Marsden - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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