Clinical trial NCT01870947: Assisted Exercise in Obese Endometrial Cancer Patients
Official title: REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Randomized Trial of Assisted Exercise in Obese Endometrial Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage I Endometrial Adenocarcinoma
Uterine Cancer
Obesity
Keywords: Stage I endometrial adenocarcinoma
Obesity
Exercise and Physical Fitness
Diet
Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight change from pre- to post-intervention
timeFrame: 24 weeks after exercise intervention (EOT)
Secondary outcomes:
measure: Change in Body Composition from baseline
timeFrame: at 4 weeks after exercise intervention(EOT)
measure: Change in Motivation to Exercise from baseline
timeFrame: 24 weeks after exercise intervention (EOT)
measure: Change in Eating Behavior from baseline
timeFrame: 24 weeks after exercise intervention (EOT)
measure: Change in Quality of Life (QoL)from baseline
timeFrame: 24 weeks after exercise intervention (EOT)
measure: Change in Depression from baseline
timeFrame: 24 weeks after exercise intervention (EOT)
measure: Exercise Session Adherence
timeFrame: 24 weeks after exercise intervention (EOT)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Nora Nock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nock NL, Dimitropoulos A, Zanotti KM, Waggoner S, Nagel C, Golubic M, Michener CM, Kirwan JP, Alberts J. Sleep, quality of life, and depression in endometrial cancer survivors with obesity seeking weight loss. Support Care Cancer. 2020 May;28(5):2311-2319. doi: 10.1007/s00520-019-05051-1. Epub 2019 Sep 2.