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Sleep and Related Disorders · Journal article
Journal of Geriatric Oncology · August 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This pilot RCT demonstrates that time-restricted eating with a 10-hour window is feasible (83.3% retention) and achievable in older adults with advanced cancer, with successful reduction in eating window from 11.6 h to 9.2 h. However, the intervention showed no significant between-group effects on fatigue or frailty—the stated clinical outcomes—though post-hoc exploratory analyses suggest associations between enhanced circadian rhythm parameters and reduced fatigue and frailty that warrant testing in larger studies.
Pilot randomized controlled trial, 1:1 allocation. Adults ≥55 years with prostate cancer receiving androgen deprivation therapy or metastatic breast cancer receiving CDK4/6 inhibitors plus aromatase inhibitor. Mean age 68.8 ± 6.4 years, 93% male (n=30 enrolled).. Intervention: Time-restricted eating with self-selected 10-hour eating window aligned with daytime hours, plus personalized nutrition counseling fortnightly for 12 weeks. Compared with: Usual eating pattern (no time restriction) plus same nutrition counseling. n = 24. Not stated.
Retention rate 83.3% (20 of 24 randomized participants completed intervention) Eating window successfully reduced in TRE group from 11.6 ± 2.4 h baseline to 9.2 ± 1.4 h weeks 1–12, compared to control 13.3 ± 1.5 h (p < 0.001) No between-group effects for fatigue, frailty, or rhythm measures (p > 0.05)
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Time-restricted eating is feasible to implement in older cancer patients but did not reduce fatigue or frailty compared to control in this small pilot. The exploratory associations between circadian rhythm parameters and supportive care outcomes suggest a possible mechanism worth investigating in a larger trial; clinicians should not yet adopt TRE as a fatigue or frailty intervention based on this evidence.
Pilot feasibility study with small sample (n=24 randomized, n=20 completed) showing no between-group effects on primary clinical outcomes; associations observed are post-hoc exploratory analyses suggesting hypothesis for future study.
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Time-restricted eating is feasible to implement in older cancer patients but did not reduce fatigue or frailty compared to control in this small pilot. The exploratory associations between circadian rhythm parameters and supportive care outcomes suggest a possible mechanism worth investigating in a larger trial; clinicians should not yet adopt TRE as a fatigue or frailty intervention based on this evidence.
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INTRODUCTION: Treatments for advanced and metastatic cancer can cause fatigue and accelerate the progression to frailty, a condition that increases vulnerabilities to stressors. Time-restricted eating (TRE) entails consuming food within a defined time window every day. TRE may help strengthen circadian rhythms and improve physiology. We present findings from a pilot study assessing the feasibility of TRE, when aligned with the daytime hours, as well as measures of fatigue, frailty, diurnal rhythms, and physiological responsiveness among people living with cancer. MATERIALS AND METHODS: Participants were eligible if they were ≥ 55 years old and had prostate cancer receiving androgen deprivation therapy (ADT) or metastatic breast cancer receiving CDK4/6 inhibitors plus an aromatase inhibitor. All participants met with a licensed dietitian/nutritionist and were provided with personalized nutrition counseling fortnightly for 12 weeks. After baseline assessments, participants were randomized 1:1 to TRE, with a self-selected 10-h eating window, or control. The primary outcomes were retention and adherence. Secondary outcomes included fatigue (FACIT-F fatigue subscale), frailty (Fried's frailty criteria), rest-activity rhythms using actigraphy, 24-h urinary hormone fluctuations (e.g., cortisol, melatonin, epinephrine, norepinephrine; dynamic range assessed as maximum-minimum), and orthostatic blood pressure change. For future hypothesis generation, effect of group was assessed using linear regression; correlations between outcomes were assessed using linear mixed models controlling for relevant confounding factors. RESULTS: Participants (n = 30, 93% male) were 68.8 ± 6.4 years old (range 57.4-81.0 y); 24 were randomized and 20 completed the intervention (83.3% retention). The average eating window was 11.6 ± 2.4 h at baseline (all participants). From weeks 1-12, the average eating window was 9.2 ± 1.4 h for the TRE group and 13.3 ± 1.5 for the control group (t-test, p < 0.001). There were no between-group effects for fatigue, frailty, or rhythm measures (p > 0.05). However, relative amplitude of rest-activity rhythms was associated with less fatigue (b ± SE = -6.3 ± 2.8, p = 0.03). Also, frailty was negatively associated with the dynamic range in urinary norepinephrine (b ± SE = -0.033 ± 0.016, p = 0.06). DISCUSSION: TRE is a feasible nutritional program for older adults living with cancer. A greater dynamic range of several circadian rhythm parameters was associated with better supportive care outcomes, suggesting that entrainment of circadian rhythms may help alleviate fatigue and frailty. A larger, phase II preliminary efficacy study is warranted. TRIAL REGISTRATION: NCT05968144.
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