This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (RT) and androgen deprivation therapy (ADT). ADT effectively slows the growth of prostate cancer cells, thereby enhancing the therapeutic effectiveness of RT. Despite the clinical gains, ADT leads to an array of side effects including insulin resistance, abnormal lipid levels, weight gain, increased visceral fat mass coupled with increased muscle wasting, and quality of life deterioration. A diet and physical activity intervention may intercept or prevent the abrupt metabolic and physiologic changes caused by androgen deprivation therapy in prostate cancer patients receiving ADT and RT.
Additional locations may be listed on ClinicalTrials.gov for NCT04870515.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Examine intervention effects on ADT-induced insulin resistance measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
II. Examine intervention effects on ADT-induced changes in anthropometry (weight and waist circumference) and body composition (fat and lean mass).
EXPLORATORY OBJECTIVES:
I. To explore intervention effects on blood lipids (total, high density lipoprotein [HDL]- and low density lipoprotein [LDL]-cholesterol) and Hemoglobin A1C (HbA1c).
II. To explore intervention effects on patient reported outcomes.
III. To explore intervention effects on gut microbiome.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (DIET AND PHYSICAL ACTIVITY): Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instructions on a modified DASH diet. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
GROUP II (CONTROL): Patients attend a single in-person or virtual session with a registered dietitian to receive standard lifestyle recommendations based on the United States (US) dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight maintenance.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorMarian Louise Stone Neuhouser
