Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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TRIPLE-A PILOT: Actively Intercepting ADT-Induced Metabolic Aberrations in Newly Diagnosed Prostate Cancer

Conditions
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Localized Prostate Carcinoma, Prostate Adenocarcinoma

Intervention / Treatment
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* Other: Best Practice
* Other: Dietary Intervention
* Other: Exercise Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (diet, physical activity)<br>Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. 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. | Other: Dietary Intervention<br>* Receive dietary instructions<br>* Other names: Nutritional Interventions;Other: Exercise Intervention<br>* Complete aerobic and strength/resistance exercises<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (standard lifestyle recommendations)<br>Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss. | Other: Best Practice<br>* Receive standard lifestyle recommendations<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of the intervention on androgen deprivation therapy (ADT)-induced changes in Homeostatic Model Assessment for Insulin Resistance | 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. | Up to 6 months | 
| Effects of the intervention on ADT-induced changes in body weight | Weight will be measured at baseline and 6 months. Will be evaluated using linear regression models. | Up to 6 months | 
| Effects of the intervention on ADT-induced changes in waist circumference | Waist (1 above umbilicus) circumferences will be measured at baseline and 6 months. Will be evaluated using linear regression models. | Up to 6 months | 
| Effects of the intervention on ADT-induced changes in lean mass | Lean mass will be measured by dual-energy x-ray absorptiometry at baseline and 6 months. Will be evaluated using linear regression models. | Up to 6 months | 
| Effects of the intervention on ADT-induced changes in fat mass | Fat mass will be measured by dual-energy x-ray absorptiometry at baseline and 6 months. Will be evaluated using linear regression models. | Up to 6 months |