Trial record 11 of 1109 for:    diarrhea

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

This study has been completed.
Sponsor:
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
  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:
Diarrhea
Uterine Cervical Neoplasms
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 April 17, 2014