Improving Energy Balance in Men With Prostate Cancer
Completed · Not applicable
Conditions studied: Prostate Cancer
In brief
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 study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.
Key facts
- Study ID
- NCT01886677
- Run by
- University of Alabama at Birmingham
- People needed
- 40
- Starts
- 2012-09-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2017-03-03
Who can join
Age: 19 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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