Status:
ACTIVE_NOT_RECRUITING
Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Prostatic Neoplasm
Survivorship
Eligibility:
All Genders
55+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Frailty affects more than 5.4 million people over the age of 65 in the United States (\>10%) and is one of the main reasons older adults lose independence. Frailty describes a reduced ability to withs...
Eligibility Criteria
Inclusion
- Inclusion criteria (Participants must…)
- 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
- Exclusion criteria (Participants must not…)
- Be on active chemotherapy or radiation for cancer
- Be underweight (≤18.5 kg/m2)
- Have lost more than 10 pounds unintentionally in the last 12 months
- Have surgery planned during the study duration
- Have had a major surgery, including hip/knee surgery, in the last 3 months
- 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)
- Already eat all their food in a window that is 10 h or shorter on most (6/7) days of the week
Exclusion
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05968144
Start Date
January 29 2024
End Date
December 31 2027
Last Update
May 1 2025
Active Locations (1)
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1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201