Effects of nutrient timing on cancer-related fatigue

Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue Among Blood Cancer Survivors (2458GCCC)

This study is testing if eating all meals within a 10-hour window can help cancer survivors with blood cancers feel less tired and improve their quality of life.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Maryland, Baltimore (other)
• Drugs / interventions: chimeric antigen receptor, chemotherapy, radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06482515 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of time-restricted eating on cancer-related fatigue in patients who have been treated for hematologic neoplasms. Participants will be required to consume all their food within a 10-hour window, which may help regulate their circadian rhythms and alleviate fatigue. The study aims to determine if this dietary approach can improve quality of life for cancer survivors experiencing persistent fatigue. Participants will receive nutrition counseling to support their dietary changes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with a hematologic neoplasm and are experiencing significant fatigue post-treatment.

Not a fit: Patients who are currently undergoing treatment for cancer or do not experience significant fatigue may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce cancer-related fatigue and improve the quality of life for survivors.

How similar studies have performed: While the concept of time-restricted eating is gaining attention, this specific application in cancer-related fatigue is relatively novel and has not been extensively tested.

Eligibility criteria

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:

  1. 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?"
  2. In the habit of taking daytime naps,
  3. 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 this trial is running

Baltimore, Maryland

• University of Maryland, Baltimore — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Study coordinator: Amber Kleckner

Conditions: Neoplasms, Blood Cancer, Fatigue, Diet Habit, Survivorship, Fasting, Intermittent