Localized Prostate CarcinomaNCT04870515
Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
A study testing Best Practice, Dietary Intervention and Exercise Intervention in people with Localized Prostate Carcinoma and Prostate Adenocarcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Localized Prostate Carcinoma, Prostate Adenocarcinoma
- What is being tested?
- Best Practice, Dietary Intervention and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 18 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: TRIPLE-A PILOT: Actively Intercepting ADT-Induced Metabolic Aberrations in Newly Diagnosed Prostate Cancer
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.
Read the 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.
- Being tested
- Best Practice, Dietary Intervention, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard lifestyle recommendations
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive dietary instructions
Exercise InterventionOther
Complete aerobic and strength/resistance exercises
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 months, 6 months
Effects of the Intervention on ADT-induced Changes in Body Weight
Change in body weight from baseline.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 0 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start4 Nov 2021
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Localized Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Marian Neuhouser, Fred Hutchinson Cancer Center
- Investigators
- Marian L. Neuhouser, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870515
- Sponsor's protocol ID
- RG1121348
- Other IDs
- NCI-2021-02762, P50CA097186, 10669
- Status last verified
- Jan 2026
- First submitted
- 19 Apr 2021
- Last updated
- 9 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No