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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04870515
Collaborator
National Cancer Institute (NCI) (NIH)
20
Enrollment
2
Locations
2
Arms
19.8
Anticipated Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Dietary Intervention
  • Other: Exercise Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 N/A

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 Unites 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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
TRIPLE-A PILOT: Actively Intercepting ADT-Induced Metabolic Aberrations in Newly Diagnosed Prostate Cancer
Actual Study Start Date :
Nov 4, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I (diet, physical activity)

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.

Other: Dietary Intervention
Receive dietary instructions
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

    • Other: Exercise Intervention
    Complete aerobic and strength/resistance exercises

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies
    Active Comparator: Group II (standard lifestyle recommendations)

    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.

    Other: Best Practice
    Receive standard lifestyle recommendations
    Other Names:
  • standard of care
  • standard therapy

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 40-70 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Veterans Affairs Puget Sound Health Care System Seattle Washington United States 98108
    2 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Marian L. Neuhouser, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04870515
    Other Study ID Numbers:
    • RG1121348
    • NCI-2021-02762
    • P50CA097186
    • 10669
    First Posted:
    May 3, 2021
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Adenocarcinoma

    Study Results

    No Results Posted as of Aug 5, 2022