Targeting HealthY Eating to Maintain Energy While Living With Cancer

NCT07826871 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HP-00119566
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Keywords

intermittent fasting; survivorship; frailty; nutrition

Outcome Measures

Primary Outcomes (1)

• Fatigue, measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)

  The Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) is a 30-item self-report questionnaire that assesses five dimensions of fatigue: General, Physical, Emotional, Mental, and Vigor. Responses are rated on a 5-point scale based on symptoms experienced during the previous week. The total fatigue score is calculated by summing the General, Physical, Emotional, and Mental Fatigue subscale scores and subtracting the Vigor subscale score. Total scores range from -24 to 96, with higher scores indicating greater fatigue.

  12 weeks

Study Arms (2)

Time-restricted eating

EXPERIMENTAL

Behavioral: Nutrition counseling; Behavioral: Time-restricted eating

Time-unrestricted eating

ACTIVE COMPARATOR

Behavioral: Nutrition counseling

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; Time-unrestricted eating

Time-restricted eating BEHAVIORAL

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

Time-restricted eating

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Intermittent Fasting; Frailty

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amber Kleckner, PhD

CONTACT

4107065961; amber.kleckner@umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2033
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)