Status:
COMPLETED
Assisted Exercise in Obese Endometrial Cancer Patients
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Stage I Endometrial Adenocarcinoma
Uterine Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 as...
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 int...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2019
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01870947
Start Date
September 7 2011
End Date
September 4 2019
Last Update
January 27 2020
Active Locations (2)
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1
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
2
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195