Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness

NCT05968144 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: HP-00106546
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Prostatic Neoplasm; Survivorship; Frailty; Aging; Metastatic Breast Cancer

Keywords

Nutrition; Circadian rhythm

Outcome Measures

Primary Outcomes (1)

• Feasibility, as assessed by the percentage of participants who enrolled completed the study

  To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.

  12 weeks

Secondary Outcomes (1)

• The effects of TRE on frailty, as measured using Fried's Frailty criteria

  12 weeks

Study Arms (2)

Time-restricted eating

EXPERIMENTAL

Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times).

Behavioral: Dietary recommendations; Behavioral: Time-restricted eating

Unrestricted eating

ACTIVE COMPARATOR

Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will try to follow recommendations will no suggestion for meal timing.

Behavioral: Dietary recommendations

Interventions

Dietary recommendations BEHAVIORAL

One-on-one meeting with a nutritionist to discuss and personalize dietary recommendations for patients with prostate cancer undergoing ADT.

Time-restricted eating; Unrestricted eating

Time-restricted eating BEHAVIORAL

12 weeks of time-restricted eating (10-hour window)

Time-restricted eating

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Frailty; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amber Kleckner, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded when possible (e.g., salivary cortisol concentration)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: January 29, 2024
• Primary Completion: July 28, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)