Know Cancer

or
forgot password

The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy


N/A
20 Years
80 Years
Not Enrolling
Both
Cervical Cancer, Diarrhea, Prostate Cancer, Radiation Toxicity, Sarcoma

Thank you

Trial Information

The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy


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.

Inclusion 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^®)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks

Outcome Time Frame:

baseline and once a week for 6 weeks

Safety Issue:

No

Principal Investigator

Amy LeJeune, MS, RD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CASE2Z05

NCT ID:

NCT00258401

Start Date:

May 2005

Completion Date:

June 2006

Related Keywords:

  • Cervical Cancer
  • Diarrhea
  • Prostate Cancer
  • Radiation Toxicity
  • Sarcoma
  • 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
  • Uterine Cervical Neoplasms
  • Diarrhea
  • Prostatic Neoplasms
  • Radiation Injuries
  • Sarcoma

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065