Exercise and Healthy Diet or Standard Care in Patients in Remission From Stage I or Stage II Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title: Survivors of Uterine Cancer Empowered By Exercise and Healthy Diet (SUCCEED)

Status Completed

Clinical Trial Summary

RATIONALE: Participating in a diet and exercise program may improve the quality of life of overweight and obese patients who are in remission from endometrial cancer.

PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to see how well it works compared with standard care in patients in remission from stage I or stage II endometrial cancer.

Clinical Trial Description

PRIMARY OBJECTIVE:

• To reduce morbidity and early mortality in endometrial cancer (EC) survivors through obesity management.

SECONDARY OBJECTIVES:

• To expand and refine a previous pilot study of a behavioral, lifestyle-change education intervention for use in overweight and obese patients in remission from endometrial carcinoma.

• To determine the potential effects and variation of each regimen in these patients.

• To explore potential mediators (self-efficacy, depression) and moderators (body mass index) of healthful dietary and exercise behaviors.

• To evaluate neuronal response to high-versus-low calorie visual food stimuli under fasted (hunger) and fed (satiated) states in brain regions of interest (hypothalamus, lateral orbitofrontal cortex, ventral striatum, insula) using blood oxygenation level dependent (BOLD) functional magnetic resonance imaging (fMRI) before and after a lifestyle (diet and exercise counseling) intervention or usual care in obese EC patients. We will also compare the neuronal responses in obese EC patients to those from normal weight subjects without cancer being seen at the same gynecologic clinic; and, explore modification of the neuronal signals by candidate genes and serum biomarkers in the hypothalamic pituitary-adrenal axis, serotonergic and inflammatory pathways.

OUTLINE: Patients are stratified according to body mass index (25.0-39.9 vs ≥ 40) and randomized to 1 of 2 intervention arms.

• Arm I: Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.

• Arm II (control): Patients receive usual care informational brochures, but no lifestyle counseling, related to weight loss, physical activity, and nutrition.

Patients undergo physician counseling sessions at baseline and 3, 6, and 12 months. Patients are assessed by weight, anthropometric measures, and body mass index; biomarkers; body composition by dual-energy x-ray absorptiometry/densitometry (DEXA); co-morbidities by the Charlson co-morbidity score; depression by the Beck Depression Inventory (BDI); eating patterns by the Three-Factor Eating Inventory (EI); exercise/physical activity by Leisure Score Index (LSI) and pedometer step count; nutrient intake by 24-hour recall; quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G) and Short-form Medical Outcomes (SF-36); and self-efficacy by the Self-Efficacy Questionnaire (SEQ) and the Weight Efficacy Life-Style (WEL). ;

Study Design

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

Related Conditions & MeSH terms

• Endometrial Cancer

• NCT number: NCT00732173
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Completion date: March 2011