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Low-Residue Diet in Treating Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis for Uterine, Cervical, or Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00258401
  Purpose

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.


Condition Intervention
Cancer-Related Problem/Condition
Cervical Cancer
Prostate Cancer
Sarcoma
Procedure: dietary intervention
Procedure: management of therapy complications
Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Diarrhea Prostate Cancer Soft Tissue Sarcoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Active Control
Official Title: The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy

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

Primary Outcome Measures:
  • Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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^®)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258401

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Alyssia Kellermier, MS, RD, LD Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000450783, CASE-2Z05, CASE-060506
Study First Received: November 22, 2005
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00258401  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
diarrhea
quality of life
radiation toxicity
recurrent uterine sarcoma
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent cervical cancer
stage 0 cervical cancer
stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer

Study placed in the following topic categories:
Diarrhea
Genital Neoplasms, Male
Prostatic Diseases
Malignant mesenchymal tumor
Quality of Life
Urogenital Neoplasms
Genital Diseases, Male
Recurrence
Soft tissue sarcomas
Neoplasms, Connective and Soft Tissue
Sarcoma
Uterine sarcoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009