Status:
COMPLETED
Improving Energy Balance in Men With Prostate Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
19+ years
Phase:
NA
Brief Summary
RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression. PURPOSE: Randomized phase II trial to st...
Detailed Description
This is a 2-arm randomized controlled feasibility trial among 40 overweight or obese men newly diagnosed with prostate cancer who are scheduled for prostatectomy. This study will use the presurgical p...
Eligibility Criteria
Inclusion
- Histopathologically confirmed prostate cancer
- Elects prostatectomy as first line treatment (i.e., no androgen ablation, radiation therapy, etc)
- Has at least 3.5 weeks lag-time until scheduled prostatectomy (must be able to participate in the diet and exercise program a full 3.5 weeks).
- Body mass index (BMI) 25 - 49.9
- Mentally competent
- Able to speak and write English
- Has telephone access
- Agrees to be randomized to either study arm (immediate or delayed diet and exercise program)
Exclusion
- Another active malignancy (not including non-melanoma skin cancer)
- Medical conditions that affect weight (e.g., untreated thyroid disturbances
- Currently on a weight loss regimen
- Preexisting medical condition(s) that preclude adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-mths, etc.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01886677
Start Date
September 1 2012
End Date
January 1 2015
Last Update
March 3 2017
Active Locations (1)
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1
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35294