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

Not Applicable

Completed

• Conditions: Prostate Adenocarcinoma; Localized Prostate Carcinoma
• Interventions: Other: Dietary Intervention; Other: Best Practice; Other: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• 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.

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Study Start: 2021-11-04
• Primary Completion: 2024-12-18
• Study Completion: 2024-12-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (diet, physical activity)	Quality-of-Life Assessment	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.
Group II (standard lifestyle recommendations)	Quality-of-Life Assessment	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.
Group I (diet, physical activity)	Dietary Intervention	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.
Group I (diet, physical activity)	Questionnaire Administration	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.
Group I (diet, physical activity)	Exercise Intervention	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.
Group II (standard lifestyle recommendations)	Best Practice	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.
Group II (standard lifestyle recommendations)	Questionnaire Administration	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.

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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States