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

Conditions:Cervical Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Age Range:Any
Start Date:July 2008

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

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.


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


- 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

- 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

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).


- 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

- No evidence of disease


- 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


- See Disease Characteristics
We found this trial at
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
Cleveland, OH
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-2273
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
Cleveland, OH
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