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REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Pilot Study of Assisted Exercise in Obese Endometrial Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Female
Stage I Endometrial Adenocarcinoma, Uterine Cancer, Obesity

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Trial Information

REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Pilot Study of 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 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Weight change from pre- to post-intervention

Outcome Time Frame:

24 weeks after exercise intervention (EOT)

Safety Issue:

No

Principal Investigator

Nora Nock, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE5811

NCT ID:

NCT01870947

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Stage I Endometrial Adenocarcinoma
  • Uterine Cancer
  • Obesity
  • Stage I endometrial adenocarcinoma
  • Obesity
  • Exercise and Physical Fitness
  • Diet
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Endometrial Neoplasms
  • Obesity
  • Uterine Neoplasms
  • Adenoma

Name

Location

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