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Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors


N/A
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer, Weight Changes

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Trial Information

Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors


OBJECTIVES:

Primary

- Determine the combined effect of exercise and dietary counseling on the weight loss and
quality of life of obese patients with stage I or II endometrial cancer in remission.

Secondary

- Determine the feasibility and acceptability of lifestyle interventions in these
patients.

OUTLINE: This is a randomized, controlled study. Patients are stratified according to age
and body mass index (25-29.9 vs ≥ 30). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo weekly contact with a dietitian; exercise intervention for 6
months; and physician counseling at baseline and at 3, 6, and 12 months. Patients
undergo quality of life assessments and clinical assessments at baseline and at 3, 6,
and 12 months.

- Arm II: Patients undergo quality of life, exercise, and clinical assessments at
baseline and at 3, 6, and 12 months.

After completion of study treatment, patients are followed at 1 year.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial cancer meeting the following criteria:

- Stage I or II disease

- Post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy

- Disease in remission

- Body Mass Index (BMI) ≥ 25

PATIENT CHARACTERISTICS:

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY: Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months

Outcome Time Frame:

baseline, 3, 6, and 12 months

Safety Issue:

No

Principal Investigator

Vivian von Gruenigen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CASE5804

NCT ID:

NCT00262938

Start Date:

February 2005

Completion Date:

August 2011

Related Keywords:

  • Endometrial Cancer
  • Weight Changes
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • weight changes
  • Body Weight Changes
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

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