Recruiting
Phase 2

Time-Restricted Eating

Sponsor:

University of Maryland, Baltimore

Code:

NCT07826871

Conditions

Fatigue in Cancer Survivors

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Nutrition counseling

Time-restricted eating

Study Details

Brief summary:

Treatments for advanced and metastatic cancer can cause fatigue and accelerate the progression to frailty. There are few effective mitigation strategies for fatigue or frailty in chronic cancer in part because the underlying etiology and pathophysiology are not well understood. However, disruption of circadian rhythms is a mechanism that possibly underlies fatigue and other components of frailty. Time-restricted eating is a daily eating pattern that entails consuming food within a defined, consistent window (e.g., 10 hours) every day. When the eating window aligns with the daylight hours, it entrains circadian processes and modulates physiological regulation of whole-body metabolism. Stronger physiological regulation means that the body will better be able to respond to physiological perturbations such as standing up from lying down, walking vs. sitting still, and eating food, as well as sleep more efficiently and have more perceived energy during the day. It is also predicted that patients will be less vulnerable to the aging process. It is hypothesized that time-restricted eating can alleviate fatigue and slow the progression to frailty in older adults with cancer as a chronic condition via regulating circadian rhythms and improving physiological responsiveness. 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). The time-restricted eating intervention is scalable and inexpensive, lending itself to accessibility for the vast majority of people living with cancer as a chronic condition. Data generated herein will be used to inform a larger, phase III multisite clinical trial testing the effects of time-restricted eating on fatigue and frailty among older adults living with cancer and further optimize interventions that entrain circadian rhythms and improve energy production.

Conditions

Fatigue in Cancer Survivors

Study ID

NCT07826871

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2033

Anticipated

Primary completion date

Sep, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Time-restricted eating

active comparator: Time-unrestricted eating

Interventions

Nutrition counseling

Participants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines.

Time-restricted eating

Participants will be asked to eat all their food in a self-selected 10-hour eating window every day.

Primary outcome measure

  • Fatigue, measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Amber Kleckner, PhD

4107065961amber.kleckner@umaryland.edu

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Amber Kleckner, PhD

410-706-5961amber.kleckner@umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • intermittent fasting
  • survivorship
  • frailty
  • nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.