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

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Prostate Adenocarcinoma; Localized Prostate Carcinoma

Treatments: Other: Best Practice; Other: Exercise Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Dietary Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04870515

RG1121348

NCI-2021-02762 (Registry Identifier)

P50CA097186 (U.S. NIH Grant/Contract)

10669 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Group I (diet, physical activity)

Experimental group

Description:

Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instruction on healthy dietary pattern. Patients also attend 2 one-on-one sessions with an exercise physiologist to receive instruction on aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.

Treatment:

Other: Dietary Intervention

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Exercise Intervention

Group II (standard lifestyle recommendations)

Active Comparator group

Description:

Patients attend a single session with a dietitian to review healthy lifestyle recommendations, including US dietary guidelines and 30 minutes of physical activity 5 days/week.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Best Practice