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

Phase

N/A

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Best Practice

Dietary Intervention

Exercise Intervention

Clinical Study ID

NCT04870515

RG1121348

P50CA097186

NCI-2021-02762

10669

Ages > 40
Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age >= 40 years
Histologically confirmed adenocarcinoma of the prostate, (D'Amico risk categoryintermediate or high risk, localized or locoregional)
Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizinghormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directedtherapies] with standard RT dose and fractionation (anti-androgen monotherapy willnot be allowed
Physically able to undertake an exercise program

Exclusion

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 significantpre-existing cardiovascular disease (CVD) (myocardial infarction or stroke withinprior six months)
Physician confirmed cognitive impairment or alcohol/narcotic abuse

Study Design

Best Practice

November 04, 2021

December 18, 2024

Study 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.

Connect with a study center

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
United States
Site Not Available
Veterans Affairs Puget Sound Health Care System
Seattle, Washington 98108
United States
Site Not Available
Fred Hutch/University of Washington Cancer Consortium
Seattle 5809844, Washington 5815135 98109
United States
Site Not Available

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