Assisted Exercise in Obese Endometrial Cancer Patients

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 12 and 24 weeks post-EOT, in obese EC patients who will be randomized
to perform 'assisted' or voluntary exercise.

Secondary Objectives:

Objective 1: To objectively examine food behavior as determined by neuronal response to high-
versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states and stop/go
signaling (SST) in fed 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 12 and 24 weeks post-intervention in obese EC patients
performing 'assisted' and voluntary exercise.

Objective 2: To examine the modification of the neuronal response to high vs. low calorie
food images in regions of interest by polymorphisms in key genes (e.g., dopamine receptor and
dopamine transporter) and serum biomarkers (e.g., leptin, BDNF) involved in regulating
homeostatic and non-homeostatic energy systems.

Patients will be randomized to receive either the assisted exercise (n=60) or voluntary
exercise (n=60) 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.

Inclusion Criteria:

- 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 4 years after completion of treatment.

- BMI ≥ 30.0 (obese)

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

- Meets screening criteria including successful completion of a cardiopulmonary stress
test

- 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 or any woman who has previously had bariatric surgery or is planning to
undergo bariatric surgery in the next 12 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