Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aging | — | UNRESOLVED | — |
| Frailty | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary recommendations | Behavioral | — | UNRESOLVED |
| Time-restricted eating | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Time-restricted eating
- description
- 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).
- interventionNames
- Behavioral: Dietary recommendations
- Behavioral: Time-restricted eating
- type
- ACTIVE_COMPARATOR
- label
- Unrestricted eating
- description
- 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.
- interventionNames
- Behavioral: Dietary recommendations
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKleckner AS, Clingan CL, James S, Addison O, Hussain A, Kleckner IR, Mohile SG, Ryan AS, Schotz K, Terrin M, Tkaczuk KHR, Wells JL. Time-restricted eating to entrain circadian rhythms, increase physiological responsiveness, and prevent stressor-induced frailty: A pilot randomized controlled trial. J Geriatr Oncol. 2026 Aug 8;17(8):103077. doi: 10.1016/j.jgo.2026.103077. Online ahead of print. PMID 42570448