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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of toxicity, defined using the Bristol Stool Chart [ Designated as safety issue: Yes ]
  • Costs for symptom management [ Designated as safety issue: No ]

Estimated Enrollment: 177
Study Start Date: October 2009
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170299

Locations
United Kingdom
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Contact Person    44-20-7808-2581    peter.blake@rmh.nhs.uk   
Sponsors and Collaborators
Royal Masonic Hospital
Investigators
Study Chair: Peter R. Blake, MD Royal Marsden NHS Foundation Trust
Investigator: Jervoise Andreyev, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01170299     History of Changes
Other Study ID Numbers: RM-FIBRE-STUDY, CDR0000681693, RM-CCR-3142, EU-21053
Study First Received: July 24, 2010
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
anal cancer
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

Additional relevant MeSH terms:
Anus Neoplasms
Urinary Bladder Neoplasms
Uterine Cervical Neoplasms
Colorectal Neoplasms
Ovarian Neoplasms
Fallopian Tube Neoplasms
Sarcoma
Radiation Injuries
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Colonic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014