Assisted Exercise in Obese Endometrial Cancer Patients
Conditions
Stage I Endometrial Adenocarcinoma - Uterine Cancer - Obesity
Conditions: official terms
Adenocarcinoma - Uterine Neoplasms
Conditions: Keywords
Stage I endometrial adenocarcinoma, Obesity, Exercise and Physical Fitness, Diet, Cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Exercise on stationary recumbent exercise cycle Type: Behavioral
Name: Health Education Type: Behavioral
Name: Questionnaires Type: Behavioral
Name: Neuroimaging Type: Procedure
Name: Genetic and Biomarkers Type: Procedure
Overall Status
Recruiting
Summary
This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain's responses to different visual images will also be assessed.
Detailed Description
Primary Objective:

To evaluate changes in body weight, fitness, bi-manual dexterity, exercise motivation and self-reported eating behavior (via questionnaires) before and after a 16-week exercise intervention (EOT)and 4 weeks post-EOT in obese EC patients who will be randomized to perform 'assisted', voluntary or no exercise (healthy living educational information only).

Secondary Objective:

To objectively examine food behavior as determined by neuronal response to high- versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states in brain regions of interest (reward and motivation circuitry) using blood oxygenation level dependent (BOLD) functional MRI before and after a 16-week exercise intervention (EOT) and 4 weeks post-intervention (EOT+4) in obese EC patients performing 'assisted', voluntary or no exercise (healthy living educational information only).

Patients will be randomized to receive either the assisted exercise (n=10), voluntary exercise (n=10) or no exercise (n=6) group. Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks. The control group will be asked to complete all exercise, body composition and fMRI testing similar to the exercise groups. Patients in the No Exercise/Educational Information Only control group will complete the same set of questionnaires as the patients in the exercise groups.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Adult (>18 years) women of all races

- Histologically confirmed Stage I ) endometrial adenocarcinoma (EC), grade 1 or 2, with no adjuvant chemotherapy. Patients will be eligible to enroll as soon as 3 months after completion of treatment but no later than 2 years after completion of treatment.

- BMI ≥ 30.0 (obese)

- Approved to be contacted by the patient's treating gynecologic oncologist

- Meets screening criteria (discussed in Section 3.4 below)

- Receives medical clearance from the patient's primary care physician (PCP) or gynecologic oncologist to exercise in this study

Exclusion Criteria:

- Individuals unable to read and provide informed consent.

- Women currently participating in a structured weight loss or exercise program in the past 6 months

- Participants who do not consent to be in the study or who will be unavailable for follow-up assessments,

- Pre-existing medical conditions that would be a barrier for participation in supervised exercise
Locations
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Status: Recruiting
Contact: Nora Nock, PhD - 216-368-5653 - nora.nock@case.edu
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Status: Recruiting
Contact: Jay Alberts, PhD - 216-445-3222 - albertj@ccf.org
Start Date
September 2011
Sponsors
Case Comprehensive Cancer Center
Source
Case Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page