Targeting HealthY Eating to Maintain Energy While Living With Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07826871
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Fatigue in Cancer Survivors

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 17, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2033

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Time-restricted eating
  • Active Comparator: Time-unrestricted eating

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland, BaltimoreBaltimoreMaryland21201
Amber Kleckner, PhD
[email protected]
4107065961

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