Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
Status
RECRUITING
Phase
NA
Age
≥ 40 Years
Enrollments
20Conditions
Localized Prostate Carcinoma, Prostate AdenocarcinomaSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Marian L. Neuhouser
- 206-667-4797
- [email protected]
Principal Investigator
- Marian L. Neuhouser
Eligibility Criteria
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 Plan
Group I (diet, physical activity)
EXPERIMENTAL
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 InterventionDescription:
Receive dietary instructionsOTHER:
Exercise InterventionDescription:
Complete aerobic and strength/resistance exercisesOTHER:
Quality-of-Life AssessmentDescription:
Ancillary studiesOTHER:
Questionnaire AdministrationDescription:
Ancillary studies
Group II (standard lifestyle recommendations)
ACTIVE_COMPARATOR
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 PracticeDescription:
Receive standard lifestyle recommendationsOTHER:
Quality-of-Life AssessmentDescription:
Ancillary studiesOTHER:
Questionnaire AdministrationDescription:
Ancillary studies
Outcome Measures
Primary Outcome Measures
Effects of the intervention on androgen deprivation therapy (ADT)-induced changes in Homeostatic Model Assessment for Insulin Resistance
Effects of the intervention on ADT-induced changes in body weight
Effects of the intervention on ADT-induced changes in waist circumference
Effects of the intervention on ADT-induced changes in lean mass
Effects of the intervention on ADT-induced changes in fat mass
Timeline
Last Updated
October 15, 2024Start Date
May 3, 2021Today
January 16, 2025Completion Date ( Estimated )
June 30, 2025
Sponsors of this trial
Lead Sponsor
Fred Hutchinson Cancer CenterCollaborating Sponsors
National Cancer Institute (NCI)
RECRUITING 
21 - 64 Years