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.
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 period to explore the potential impact of weight loss via a healthy energy-restricted diet and increased physical activity on circulating hormones, cytokines, and growth factors, as well as effects on tumor biology and other clinical outcomes. Consenting patients will be block randomized to 1-of-2 study arms: 1) a healthful diet + exercise intervention to promote a weight loss of up to 2 pounds/week; or 2) a wait-list control who will receive the intervention once the study period is complete. Both groups will receive nutritional counseling during the study period to correct nutritional deficiencies with food sources. This study will explore and contrast changes in body mass index (BMI) observed over the study period (minimum of 3.5 weeks) in the intervention vs. wait-list control arms, and also monitor changes in body composition, energy intake and physical activity; these changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor immunohistochemical markers of insulin receptor, vascular endothelial growth factor (VEGF), AKT, and nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB); and d) functional and health-related outcomes, i.e., side-effects and medical outcomes, quality of life (QoL), and functional status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).
Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Tumor Proliferation Rate (Ki-67)
Changes in tumor proliferation rate (Ki-67) over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms.
Time frame: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)
Changes in body weight and composition, energy intake and physical activity
Changes in body composition, energy intake and physical activity over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms.
Time frame: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)
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