Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
- Conditions
- Prostate AdenocarcinomaLocalized Prostate Carcinoma
- Registration Number
- NCT04870515
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- Age >= 40 years
- Histologically confirmed adenocarcinoma of the prostate, (D'Amico risk category intermediate or high risk, localized or locoregional)
- Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directed therapies] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed
- Physically able to undertake an exercise program
- Advanced, metastatic disease
- Planning to join a commercial/structured diet change or fitness program
- Have significant pre-existing T2D (poor glycemic control while on medication, defined as hemoglobin A1c of >= 10 within the prior 12 months) or significant pre-existing cardiovascular disease (CVD) (myocardial infarction or stroke within prior six months)
- Physician confirmed cognitive impairment or alcohol/narcotic abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Effects of the intervention on ADT-induced changes in lean mass Up to 6 months Lean mass will be measured by dual-energy x-ray absorptiometry at baseline and 6 months. Will be evaluated using linear regression models.
Effects of the intervention on ADT-induced changes in waist circumference Up to 6 months Waist (1" above umbilicus) circumferences will be measured at baseline and 6 months. Will be evaluated using linear regression models.
Effects of the intervention on ADT-induced changes in body weight Up to 6 months Weight will be measured at baseline and 6 months. Will be evaluated using linear regression models.
Effects of the intervention on ADT-induced changes in fat mass Up to 6 months Fat mass will be measured by dual-energy x-ray absorptiometry at baseline and 6 months. Will be evaluated using linear regression models.
Effects of the intervention on androgen deprivation therapy (ADT)-induced changes in Homeostatic Model Assessment for Insulin Resistance Up to 6 months Homeostatic model assessment of insulin resistance (HOMA-IR) will be computed from glucose and insulin concentrations. Compare change in HOMA-IR levels relative to baseline between intervention and control participants. Will be evaluated using linear regression models.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fred Hutch/University of Washington Cancer Consortium
🇺🇸Seattle, Washington, United States
Fred Hutch/University of Washington Cancer Consortium🇺🇸Seattle, Washington, United States