A Phase 2 interventional study of Nutrition counseling and Time-restricted eating in Fatigue in Cancer Survivors, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Supportive care
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.
333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.
This study's planned enrollment of 132 is above the median of 50 across 320 interventional studies indexed under Intermittent Fasting.
Browse Intermittent Fasting studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Nutrition counseling · Behavioral: Time-restricted eating
Behavioral: Nutrition counseling
Participants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines.
Participants will be asked to eat all their food in a self-selected 10-hour eating window every day.
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.
Time frame: 12 weeks
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Maryland, Baltimore →