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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00258401 |
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 |
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Cancer-Related Problem/Condition Cervical Cancer Prostate Cancer Sarcoma |
Procedure: dietary intervention Procedure: management of therapy complications Procedure: quality-of-life assessment |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | May 2005 |
OBJECTIVES:
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).
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Alyssia Kellermier, MS, RD, LD | Case Comprehensive Cancer Center |
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 |
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 |
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 |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site |