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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-04

Study Completion Date

2024-12-18

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.

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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.

Conditions

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Localized Prostate Carcinoma Prostate Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I (diet, physical activity)

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.

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

Receive dietary instructions

Exercise Intervention

Intervention Type OTHER

Complete aerobic and strength/resistance exercises

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (standard lifestyle recommendations)

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard lifestyle recommendations

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard lifestyle recommendations

Intervention Type OTHER

Dietary Intervention

Receive dietary instructions

Intervention Type OTHER

Exercise Intervention

Complete aerobic and strength/resistance exercises

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions Quality of Life Assessment

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

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No