NCT05968144Active, not recruitingPhase 1/2
Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness
ADRIAN: Towards Understanding of ADT Treatment and Dietary Patterns, Circadian Rhythm, Physiological Responsiveness, and Frailty
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Jul 2023
- Start date
- 29 Jan 2024
- Primary completion date
- 28 Jul 2025
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Prostate cancer, Metastatic breast cancer
- NCT number
- NCT05968144
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 29 Jan 2024 to the primary completion date, 28 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have surgery planned during the study duration
- Have had a major surgery, including hip/knee surgery, in the last 3 months
Other illness
- Be on active chemotherapy or radiation for cancer
- Have documented advanced liver, heart, or lung disease
- Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, recent history of an eating disorder, on artificial nutrition)
Other
- Be underweight (≤18.5 kg/m2)
- Have lost more than 10 pounds unintentionally in the last 12 months
- Already eat all their food in a window that is 10 h or shorter on most (6/7) days of the week
Who the study is looking for
- Have a diagnosis of prostate cancer or breast cancer
- Be undergoing hormone therapy (e.g., androgen deprivation therapy)
- Be 55 years old or older
- Speak and/or read English
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland, Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.