Brief Title
Exercise and Healthy Diet or Standard Care in Patients in Remission From Stage I or Stage II Endometrial Cancer
Official Title
Survivors of Uterine Cancer Empowered By Exercise and Healthy Diet (SUCCEED)
Brief 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.
Detailed 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 Type
Interventional
Primary Outcome
Weight change
Secondary Outcome
Quantitative and qualitative nutrient intake
Condition
Endometrial Cancer
Intervention
behavioral dietary intervention
Study Arms / Comparison Groups
Arm I
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
74
Start Date
July 2008
Completion Date
March 2011
Primary Completion Date
March 2010
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage I or II (early) endometrial carcinoma
- Diagnosed within the past 3 years
- Underwent prior surgery consisting of a total abdominal hysterectomy and bilateral
salpingo-oophorectomy
- No evidence of disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- BMI ≥ 25 (overweight/obese)
- Medical clearance from primary care physician
- Approved for contact by treating gynecologic oncologist
- At least a 6th-grade reading level to complete significant reading and homework
- No severe psychiatric illness (e.g., schizophrenia, bipolar disorder) or major
depression (Beck Depression Inventory > 29) that needs more aggressive,
problem-focused interventions
- No dementia or cognitive deficits
- No pre-existing medical conditions that would be a barrier for participation in
unsupervised walking
- No participation in a structured weight loss or exercise program in the past 6 months
- Must agree to and be available for longitudinal follow-up assessments
- Non-English speakers may bring an English-speaking person to all group sessions and
visits
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Peter G. Rose, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00732173
Organization ID
CASE8808
Secondary IDs
P30CA043703
Responsible Party
Sponsor
Study Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Peter G. Rose, MD, Principal Investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Verification Date
February 2013