Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy.
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00258401
First received: November 22, 2005
Last updated: January 11, 2011
Last verified: January 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|
|
Cervical Cancer Diarrhea Prostate Cancer Radiation Toxicity Sarcoma |
Dietary Supplement: dietary intervention Procedure: management of therapy complications Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy |
Resource links provided by NLM:
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks [ Time Frame: baseline and once a week for 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | May 2005 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
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.
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.
|
|
Active Comparator: no dietary intervention
At the onset of diarrhea symptoms, patients undergo no dietary intervention but are interviewed weekly for up to six 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.
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.
|
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 Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Study Chair: | Amy LeJeune, MS, RD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amy LeJeune, MS,RD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00258401 History of Changes |
| Other Study ID Numbers: | CASE2Z05, P30CA043703, CASE-2Z05, 06-05-06 |
| Study First Received: | November 22, 2005 |
| Last Updated: | January 11, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
diarrhea 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 |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Diarrhea Prostatic Neoplasms Radiation Injuries Sarcoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Signs and Symptoms, Digestive Signs and Symptoms Genital Neoplasms, Male Genital Diseases, Male Prostatic Diseases Wounds and Injuries Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 21, 2013