NCT06482515 · University of Maryland, Baltimore
Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue
What this study is about
Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated.
View original scientific description
Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated. The fatigue can be so bad that people cannot return to work, hobbies, family roles, or other daily activities, thereby greatly reducing quality of life. The causes of this fatigue are unknown, and we currently do not have anything that can reliably prevent or cure the fatigue. However, there are recent data suggesting that circadian rhythm, or a person's internal body clock, may be disrupted by the cancer experience and contribute to fatigue. Food intake is an external cue that can entrain circadian rhythm. We recently showed that cancer survivors are willing and able to eat all their food within a 10-hour eating window-a practice called time-restricted eating. Herein, we are testing time-restricted eating against a control group (matched for time-, attention, and expectancy) to see if time-restricted eating can indeed alleviate cancer-related fatigue. All participants will be asked to use the myCircadianClock smartphone app to log their food intake and weekly body weight measurements. The participants assigned to the time-restricted eating group will be asked to eat all their food in a 10-hour window during the day. People can choose their start time based on their schedule and preferences, but we ask that the window is the same for the whole study (e.g., 7am-5pm,9:30am-7:30pm). Black coffee and unsweetened tea are allowed before the eating window, and water and medicines are allowed at all times. The participants in the control group will meet with a nutritionist to discuss the American Cancer Society nutrition guidelines in cancer survivorship; they will not be restricted to when they can eat. Participants in both groups will give us valuable information regarding how diet is related to the experience of fatigue. The purpose of this study is to test the effects of a 12-week TRE intervention vs. an unrestricted eating pattern on fatigue, the sustainability of the program at 24 weeks, and the effects of TRE on circadian rhythm and sugar metabolism.
Interventions
BEHAVIORAL
Time-restricted eating
Participants will be asked to eat all their food in a self-selected 10-hour eating window every day.
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.
Primary outcome measures
Fatigue
Time frame: baseline, 6 weeks, 12 weeks
Multidimensional Fatigue Symptom Inventory-Short Form; the total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of fatigue
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (Participants must…):
- Have a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma);
- Be at least 2 months post-treatment with chemotherapy, radiation, targeted therapy, chimeric antigen receptor (CAR)-T cell therapy, stem cell transplant, or another therapy (maintenance therapies are okay; steady unchanged treatment for relapsed disease for \>2 months and expected to stay on it until progression is okay);
- Have a baseline level of fatigue, as determined by at least one of the following:
- Reporting a score of 4 or higher in response to the question, "What was your worst fatigue in the last week, on a scale of 0-10, where 0 is no fatigue and 10 is the worst fatigue?"
- In the habit of taking daytime naps,
- Have fatigue that interferes with their ability to work, engage in social events, or is more than would be expected from physical exertion,
- Be able to speak and/or read and write in English or Spanish;
- Be at least 18 years old; and
- Be able to provide informed consent.
Exclusion criteria
- (participants must not…)
- Be underweight, as defined as a body mass index \<18.5 kg/m2;
- Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week;
- Be employed in a job where they regularly work away from the home at night (e.g., night shift);
- Have surgery planned during the study duration;
- Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder);
- Be taking insulin; or
- Be on enteral or parenteral nutrition.
Where
- Baltimore, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations