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

NCT04870515 | Completed Results

• 4 other identifiers: RG1121348NCI-2021-02762P50CA09718610669
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Prostate Carcinoma; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (5)

• Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Data is reported as a percentage change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score from baseline. HOMA-IR is an index to estimate the insulin resistance of a patient. HOMA-IR is defined as (glucose (mg/dl) insulin (uIU/ml)) / 405.

  0 months, 6 months

• Effects of the Intervention on ADT-induced Changes in Body Weight

  Change in body weight from baseline.

  0 months, 6 months

• Effects of the Intervention on ADT-induced Changes in Waist Circumference

  Change in waist circumference from baseline. Waist circumference was measured at 1" above umbilicus.

  0 months, 6 months

• Effects of the Intervention on ADT-induced Changes in Lean Mass

  Change in lean mass from baseline. Lean mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).

  0 months, 6 months

• Effects of the Intervention on ADT-induced Changes in Fat Mass

  Change in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).

  0 months, 6 months

Study Arms (2)

Group I (diet, physical activity)

EXPERIMENTAL

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.

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

Group II (standard lifestyle recommendations)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (diet, physical activity); Group II (standard lifestyle recommendations)

Questionnaire Administration OTHER

Ancillary studies

Group I (diet, physical activity); Group II (standard lifestyle recommendations)

Best Practice OTHER

Receive standard lifestyle recommendations

Also known as: standard of care, standard therapy

Group II (standard lifestyle recommendations)

Dietary Intervention OTHER

Receive dietary instructions

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Group I (diet, physical activity)

Exercise Intervention OTHER

Complete aerobic and strength/resistance exercises

Group I (diet, physical activity)

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Diet Therapy

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Nutrition Therapy; Therapeutics

Limitations and Caveats

This is a pilot feasibility study with a sample size of 20 participants. Results should be interpreted accordingly.

Results Point of Contact

• Title: Marian L. Neuhouser, PhD
• Organization: Fred Hutch Cancer Center

mneuhous@fredhutch.org

206-667-4797

Study Officials

• Marian L. Neuhouser

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 3, 2021
• Study Start: November 4, 2021
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: January 9, 2026
• Results First Posted: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)