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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01170299
First received: July 24, 2010
Last updated: August 9, 2013
Last verified: July 2010

July 24, 2010
August 9, 2013
October 2009
April 2012   (final data collection date for primary 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 [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01170299 on ClinicalTrials.gov Archive Site
  • Incidence of toxicity, defined using the Bristol Stool Chart [ Designated as safety issue: Yes ]
  • Costs for symptom management [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
177
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Not Provided
United Kingdom
 
NCT01170299
RM-FIBRE-STUDY, CDR0000681693, RM-CCR-3142, EU-21053
Not Provided
Not Provided
Royal Masonic Hospital
Not Provided
Study Chair: Peter R. Blake, MD Royal Marsden NHS Foundation Trust
Investigator: Jervoise Andreyev, MD Royal Marsden NHS Foundation Trust
National Cancer Institute (NCI)
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP