Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy.

July 23, 2020 updated by: Case Comprehensive Cancer Center

The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy

RATIONALE: Eating a diet low in residue (fiber, fat, and certain milk or vegetable products) may help prevent or reduce diarrhea caused by pelvic radiation therapy.

PURPOSE: This randomized clinical trial is studying a low-residue diet to see how well it works compared to no dietary intervention in treating diarrhea in patients who are undergoing radiation therapy to the pelvis for uterine, cervical, or prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the nutritional status, Common Toxicity Criteria (CTC) score, and fecal incontinence quality of life (FI-QOL) in patients with uterine, cervical, or prostate cancer who are undergoing pelvic radiotherapy receiving a low-residue diet vs no dietary intervention.
  • Compare changes in the CTC score and FI-QOL in patients receiving a low-residue diet vs no dietary intervention.
  • Compare the efficacy, in terms of a lower CTC score or higher perceived FI-QOL, of a low-residue diet vs no dietary intervention in these patients.

OUTLINE: This is a parallel, randomized, controlled, pilot study. Patients are stratified according to cancer type. Patients are randomized to 1 of 2 treatment arms.

All patients are interviewed to obtain a baseline grade of diarrhea (according to NCI's Common Toxicity Criteria [CTC] scale) and dietary history and measure Fecal Incontinence Quality of Life (FI-QOL).

  • Arm I (intervention): At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks. They are interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
  • Arm II (control): Patients undergo no dietary intervention but are interviewed as in arm I.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of uterine, cervical, or prostate cancer
  • Current patient at the Ireland/Case Comprehensive Cancer Center
  • Planning pelvic radiation therapy within the next 4 months

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Gastrointestinal

  • No enteric support
  • No inflammatory bowel disease

Other

  • No other concurrent illness or medical condition that would preclude study compliance
  • No history of allergies or dietary intolerances (e.g., lactose intolerance) that would preclude study treatment or interfere with study results

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent hormonal therapy allowed (e.g., testosterone suppression)

Radiotherapy

  • See Disease Characteristics

Surgery

  • No prior colectomy

Other

  • No concurrent glutamine, psyllium, or other fiber supplements (e.g., Benefiber^® or Metamucil^®)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: low-residue diet
At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.Patients are interviewed weekly for up to six weeks.
Dietary supplement: dietary intervention
At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.
Procedure: management of therapy complications
Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
Procedure: quality-of-life assessment
Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
Active Comparator: no dietary intervention
At the onset of diarrhea symptoms, patients undergo no dietary intervention but are interviewed weekly for up to six weeks.
Procedure: management of therapy complications
Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
Procedure: quality-of-life assessment
Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks
Time Frame: baseline and once a week for 6 weeks
baseline and once a week for 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Study Chair: Amy LeJeune, MS, RD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 22, 2005

First Submitted That Met QC Criteria

November 22, 2005

First Posted (Estimate)

November 24, 2005

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE2Z05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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