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

Not Applicable

Completed

• Conditions: Diarrhea; Prostate Cancer; Sarcoma; Cervical Cancer; Radiation Toxicity
• Interventions: Procedure: management of therapy complications; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment

• Registration Number: NCT00258401
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-24
• Primary Completion: 2006-05
• Study Completion: 2006-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-residue diet	quality-of-life assessment	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.
no dietary intervention	management of therapy complications	At the onset of diarrhea symptoms, patients undergo no dietary intervention but are interviewed weekly for up to six weeks.
low-residue diet	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.Patients are interviewed weekly for up to six weeks.
low-residue diet	management of therapy complications	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.
no dietary intervention	quality-of-life assessment	At the onset of diarrhea symptoms, patients undergo no dietary intervention but are interviewed weekly for up to six weeks.

Primary Outcome Measures

Name	Time	Method
Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks	baseline and once a week for 6 weeks

Trial Locations

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States