Registry update — unassessed
Targeting Healthy Eating to Maintain Energy While Living With Cancer (THYME) (2668GCCC)
Trial registry update: NOT_YET_RECRUITING. No results reported in the supplied registry record.
RCTN=132Routine significance
What this changes
The finding has not established an approved change to our evidence assessment.
Source date: Sep 17, 2026 · Discovered: Sep 19, 2026 · Assessed: — · Research update
What it does not prove
- This is a protocol/trial design paper, not a results report—no efficacy outcomes are presented, so the intervention's actual effect on fatigue or frailty remains unknown.
- The study was powered as a phase II trial to inform a future phase III trial, meaning it was not designed to detect or confirm clinically meaningful effects.
- Causality cannot be inferred from the mechanistic pathway proposed (circadian rhythm entrainment) without direct evidence linking the intervention to both rhythm changes and symptom improvement.
Extracted from supplied source material; model confidence is not a measured probability of correctness.
Study details
- Design
- Rct
- Sample size
- 132
- Duration
- 12 months
- Population
- Patients aged 55 years or older with prostate cancer or metastatic breast cancer, with baseline eating window >12 hours, not employed in night-shift work
- Primary outcome
- Patient-reported fatigue
- Effect size
- —
- Significance
- Not reported
- Journal
- University of Maryland, Baltimore
- Published
- Sep 17, 2026
Sources
Primary source
- University of Maryland, Baltimore ↗Clinical trial
Recorded source passages
Abstract or registry material supplied for assessment; source version 1. This is not a claim of full-text review.
This project is a 12-week, two-arm, phase II randomized controlled trial comparing the effects of time-restricted eating (10 h daytime feeding/14 h fasting at night) vs. a nutrition counseling control intervention (no time component) on fatigue; 6- and 12-month follow-up time points are also planned.
A total of 132 patients with prostate cancer or metastatic breast cancer will be recruited; eligible participants will be 55 years or older, consume food within a window that is >12 h at baseline, and not be employed in night-shift work.
They will be randomized 1:1, intervention: control.
At baseline, 12 weeks (post-intervention), and 12 months, we will assess patient-reported fatigue (Aim 1); frailty via Fried's frailty criteria (Aim 2); and measures of circadian rhythms (i.e., rest-activity rhythm, urinary hormones) and physiological responsiveness (i.e., lying vs. standing blood pressure, sitting vs. walking heart rate, glucose tolerance, phosphocreatine recovery) (Aim 3, mechanistic aim).
Source versions
Assessment history
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