This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dietary intervention
University at Buffalo/Great Lakes Cancer Center
Buffalo, New York, United States
RECRUITINGEnrollment rate
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
Time frame: 3 years
Drop-out rate
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
Time frame: 3 years
Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.
Clinical efficacy of the combination of intermittent fasting with or without a plant-enriched diet plus androgen deprivation therapy
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Safety, tolerability and reduction of common toxicities of the combination of intermittent fasting and the option of a plant-enriched diet intervention as compared to historical data.
Time frame: 3 years
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