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

NCT ID: NCT00258401

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-06-30

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.

Conditions

Cervical Cancer; Diarrhea; Prostate Cancer; Radiation Toxicity; Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.

management of therapy complications

Intervention Type: PROCEDURE

Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.

quality-of-life assessment

Intervention Type: PROCEDURE

Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.

no dietary intervention

At the onset of diarrhea symptoms, patients undergo no dietary intervention but are interviewed weekly for up to six weeks.

Group Type: ACTIVE_COMPARATOR

management of therapy complications

Intervention Type: PROCEDURE

Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.

quality-of-life assessment

Intervention Type: PROCEDURE

Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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^®)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Principal Investigators

Amy LeJeune, MS, RD

Role: STUDY_CHAIR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE2Z05

Identifier Type: -

Identifier Source: org_study_id