Time-restricted eating to help energy and fatigue in prostate or metastatic breast cancer
Official title: Targeting Healthy Eating to Maintain Energy While Living With Cancer (THYME) (2668GCCC)
Run by University of Maryland, Baltimore · NCT07826871 · Data updated 2026-11-12
This study tests whether eating all daily calories within a fixed window can improve energy and reduce frailty for adults with certain cancers who have fatigue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | November 2026 |
| Main results expected | September 2031 |
| Study ends | September 2033 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07826871 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 55+, with prostate cancer or metastatic breast cancer on or previously treated with hormone therapy, who typically eat over a window longer than 12 hours and can communicate in English.
✕Probably not a fit
Patients with certain medical conditions or lifestyle factors (e.g., recent time-zone travel, extensive overnight shift work, or contraindications to time-restricted eating) may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial examines time-restricted eating combined with nutrition counseling for adults aged 55 and older with prostate cancer or metastatic breast cancer who are on or have a history of hormone therapy. The approach aims to realign circadian rhythms and improve metabolic regulation to mitigate fatigue and frailty associated with cancer treatment. Participants will receive nutrition counseling and follow a daily eating window, with outcomes focusing on energy levels and functional status. The study is conducted at the University of Maryland, Baltimore, and targets individuals who meet specific inclusion criteria while excluding those with certain medical or logistical contraindications. Results from this trial could inform non-drug strategies to support survivorship in this population.
Why it matters
Potential benefit: If successful, participants may experience improved energy and daily functioning through a circadian-aligned eating pattern.
How similar studies have gone: Other studies in time-restricted eating and cancer survivorship have shown potential benefits, but this specific approach in prostate and metastatic breast cancer is still emerging.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a diagnosis of prostate cancer or metastatic breast cancer * Have current use or a history of hormone therapy (e.g., androgen deprivation therapy, aromatase inhibitors) * Have a life expectancy of ≥1 year * Be 55 years of age or older * Typically consume food within a window that is greater than 12 hours * Be able to communicate in English * Have a body mass index (BMI) ≥18.5 kg/m\^2 Exclusion Criteria: * Be employed in overnight shift work more than 1 day/week on average * Be on enteral or parenteral nutrition * Have any contraindications to the proposed intervention as identified by their medical provider (e.g., type 1 diabetes, pregnancy, recent history of an eating disorder, recent bariatric surgery, insulin dependency) * Have had time zone travel ≥2 time zones away within the last 4 weeks, or have time zone travel (≥2 time zones away) planned for more than 2 days in the next 14 weeks.
Where it's running
-
University of Maryland, Baltimore
Baltimore, Maryland, United States Recruiting
Study contacts
- Study coordinator: Amber Kleckner, PhD
- Email: amber.kleckner@umaryland.edu
- Phone: 4107065961
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.