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

NCT00258401 | Completed DMC

• 1 other identifier: CASE2Z05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer; Diarrhea; Prostate Cancer; Radiation Toxicity; Sarcoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

low-residue diet

ACTIVE COMPARATOR

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; Procedure: management of therapy complications; Procedure: quality-of-life assessment

no dietary intervention

ACTIVE COMPARATOR

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; Procedure: quality-of-life assessment

Interventions

dietary intervention DIETARY_SUPPLEMENT

At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.

low-residue diet

management of therapy complications PROCEDURE

Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.

low-residue diet; no dietary intervention

quality-of-life assessment PROCEDURE

Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.

low-residue diet; no dietary intervention

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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\^®)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Diarrhea; Prostatic Neoplasms; Radiation Injuries; Sarcoma; Uterine Cervical Dysplasia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Amy LeJeune, MS, RD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: June 1, 2006
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

US (1)