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NCT04870515 · ClinicalTrials.gov registry record · NA
Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
A NA study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT04870515: Completed NA study, sponsored by Fred Hutchinson Cancer Center.
NCT04870515 is a NA study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04870515, a NA study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- OTHER Exercise Intervention
- OTHER Best Practice
- OTHER Dietary Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-11-04 |
| Est. Completion | 2024-12-18 |
| Phase | NA |
What the finished NCT04870515 record still lists
NCT04870515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04870515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04870515 about?
NCT04870515 is a clinical study titled "Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study". 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...
What is the current status of trial NCT04870515?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2021-11-04. Estimated completion is 2024-12-18.
What interventions are being tested in trial NCT04870515?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Exercise Intervention (OTHER), Best Practice (OTHER), Dietary Intervention (OTHER).
Who is sponsoring clinical trial NCT04870515?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04870515's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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