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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258401
• Other study ID #: CASE2Z05
• Status: Completed
• Phase: N/A
• Start date: May 2005
• Est. completion date: June 2006

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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^®)

Related Conditions & MeSH terms

• Cervical Cancer
• Diarrhea
• Prostate Cancer
• Prostatic Neoplasms
• Radiation Toxicity
• Sarcoma
• Uterine Cervical Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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