Assisted Exercise in Obese Endometrial Cancer Patients

Completed · Not applicable

Conditions studied: Stage I Endometrial Adenocarcinoma, Uterine Cancer, Obesity

In brief

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.

Key facts

Study ID

NCT01870947

Run by

Case Comprehensive Cancer Center

People needed

95

Starts

2011-09-07

Expected to finish

2019-09-04

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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