role of race in nutritional approach in men on adt

Conditions: Prostate Cancer Metastatic Disease

Summary: there is a well-documented association between androgen deprivation therapy (adt) and cardiovascular morbidity. a majority of men on adt gain weight contributing to an increase in cardiovascular risk factors (cvrfs) and cardiovascular morbidity. dietary intervention combined with exercise have shown success in reducing weight/fat mass and improving cardiovascular risk factors (cvrf). there is little data on whether african american men would respond to diet and exercise interventions differently from non-hispanic white men. we will conduct a pilot, controlled two-phase intervention study stratified by race to investigate the following objectives: 1. compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between african- american vs non-hispanic white men with metastatic prostate cancer on adt therapy. 2. compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and hba1c) and inflammatory markers (hs-crp and cytokines) between african-american vs non-hispanic white men with metastatic prostate cancer on adt therapy. 3. compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between african-american vs non-hispanic white men with metastatic prostate cancer on adt therapy. we will enroll 35 african american and 35 non-hispanic white men with prostate cancer undergoing adt therapy. in phase 1, after baseline assessment, men will consume their habitual diet and continue their habitual activity level for 3 months. during phase 2, participants will be instructed to consume a hypocaloric (-500 kcal), anti- inflammatory diet and walk for 1 hour on 3 days per week for 3 months. at baseline, after phase 1 and 2 primary outcome (fat mass) and secondary outcomes (cvrf and inflammatory markers) and tertiary outcomes (cancer-related fatigue and quality of life) will be determined.


Eligibility criteria:
inclusion criteria: * \>12 months on adt * expected continuation of adt for \>6 months upon initiation of study procedures * serum testosterone \<50 ng/dl * bmi \>25 * age \>18 years old * african american and non-hispanic white males * subjects must read and sign the institutional review board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. a subject will be excluded for any condition that might compromise the ability to give truly informed consent exclusion criteria: * life expectancy \< 1 year * females * radiation or chemotherapy treatment * history of diabetes or serious medical condition including uncontrolled hypertension, liver, kidney, and cardiovascular disease * any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator * any subject who currently uses tobacco products * any use of \>20 g of alcohol per day * any subject who is unable or unwilling to comply with the study protocol * any subject who is unable to provide consent

Keywords: adt cardiovascular risk factors