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


N/A
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

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Trial Information

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


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).

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Weight change

Outcome Description:

Analysis will be carried out by fitting a mixed model. Weight change will be expressed in terms of absolute and relative weight change. In addition, percent weight change will be calculated. To test the null hypotheses that the groups do not differ in terms of change in weight at 6 or 12 months, parameter estimates from the model will be used to construct subsequent t-test that the difference in means at 3, 6, or 12 months is zero.

Outcome Time Frame:

at baseline and 3, 6, and 12 months.

Safety Issue:

No

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE8808

NCT ID:

NCT00732173

Start Date:

July 2008

Completion Date:

March 2011

Related Keywords:

  • Endometrial Cancer
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

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