Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Aging and Metastatic Breast Cancer, sponsored by University of Maryland, Baltimore.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
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 |
What the registry record for NCT05968144 still lists
NCT05968144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Aging
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05968144's enrollment target sits among peer trials
30 193rd of 262 higher than 60 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging 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
-
Effect of a Daily Supplement on Plasma PAI-1 Levels
RECRUITING · Phase 1
-
MTOR Inhibitors in Older Adults
RECRUITING · Phase 1
-
Rapalog Pharmacology (RAP PAC) Study
RECRUITING · Phase 1
-
Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults
RECRUITING · Phase 1
-
Fisetin to Improve Vascular Function in Older Adults
ACTIVE NOT RECRUITING · Phase 1
-
Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI