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NCT05968144 · ClinicalTrials.gov registry record · Phase 1
Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness
A Phase 1 study of Aging and Metastatic Breast Cancer, sponsored by University of Maryland, Baltimore.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05968144 is a Phase 1 study of Aging and Metastatic Breast Cancer that is active but no longer recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 30 participants, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05968144, a Phase 1 study of Aging and Metastatic Breast Cancer, is active but no longer recruiting, sponsored by University of Maryland, Baltimore.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Frailty is one of the main reasons older adults lose independence. Frailty describes a reduced ability to withstand stress on the physiological scale, or a reduced physiological reserve. The theory is that entrainment of circadian rhythm via time-restricted eating will improve the body's ability to predict energy supply and demand, and therefore enable the body to allocate more resources to anabolic processes and promote resilience to cancer treatment, thereby preventing the progression of frailty. A total of 30 individuals over 55 years old undergoing ADT therapy for prostate cancer will be recruited. Participants will be randomized 1:1 to a 12-week TRE intervention or a time-unrestricted nutrition control intervention. At baseline and post-intervention, Fried's Frailty Index will be used to assess frailty, and a novel set of five physiological responsiveness measures will be used to assess physiological responsiveness-1) lying-to-standing blood pressure, 2) heart rate variability, 3) oral glucose tolerance test, 4) 24-hour circadian cortisol rhythm, and 5) usual vs. fast gait speed. These data will allow assessment of 1) the feasibility of TRE among patients with prostate cancer during ADT treatment with the ultimate goal of optimizing an intervention to prevent the progression of frailty, and 2) the effects of TRE vs. control on frailty and physiological responsiveness.
Conditions Studied
Interventions
- BEHAVIORAL Time-restricted eating
- BEHAVIORAL Dietary recommendations
Study Locations (1)
Maryland
- University of Maryland, Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-01-29 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05968144
The ClinicalTrials.gov registry entry for NCT05968144 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Aging appearing as the primary indexed condition, and to 2 interventions - of which Time-restricted eating is the first listed.
NCT05968144 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05968144 about?
NCT05968144 is a clinical study titled "Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness". Frailty is one of the main reasons older adults lose independence. Frailty describes a reduced ability to withstand stress on the physiological scale, or a reduced physiological reserve. The theory is that entrainment of circadian rhythm via time-restricted eating will improve the body's ability to ...
What is the current status of trial NCT05968144?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-01-29. Estimated completion is 2027-12-31.
What conditions does trial NCT05968144 study?
This clinical trial studies the following conditions: Aging, Metastatic Breast Cancer, Frailty, Survivorship, Prostatic Neoplasm.
What interventions are being tested in trial NCT05968144?
The interventions under investigation include: Time-restricted eating (BEHAVIORAL), Dietary recommendations (BEHAVIORAL).
Who is sponsoring clinical trial NCT05968144?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05968144 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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