Clinical trial NCT00732173: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: stage I endometrial carcinoma
stage II endometrial carcinoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-08-11
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

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

Primary outcomes:
measure: Weight change
timeFrame: at baseline and 3, 6, and 12 months.
Secondary outcomes:
measure: Quantitative and qualitative nutrient intake
timeFrame: at baseline and 3, 6, and 12 months.
measure: Minutes spent in moderate and vigorous physical activity
timeFrame: at baseline and 3, 6, and 12 months.
measure: Body composition, using dual energy x-ray absorptiometry/densitometry (DEXA) methodology
timeFrame: at baseline and 3, 6, and 12 months.
measure: Biomarkers for metabolic syndrome and nutrition
timeFrame: at baseline and 3, 6, and 12 months.
measure: Self-efficacy
timeFrame: at baseline and 3, 6, and 12 months.
measure: Depression
timeFrame: at baseline and 3, 6, and 12 months.
measure: Quality of life
timeFrame: at baseline and 3, 6, and 12 months.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Peter G. Rose, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Vivian von Gruenigen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Gruenigen VE, Waggoner SE, Frasure HE, Kavanagh MB, Janata JW, Rose PG, Courneya KS, Lerner E. Lifestyle challenges in endometrial cancer survivorship. Obstet Gynecol. 2011 Jan;117(1):93-100. doi: 10.1097/AOG.0b013e31820205b3.