# Time-restricted eating to address cancer-related fatigue among survivors of hematological malignancies

> **NIH NIH R01** · UNIVERSITY OF MARYLAND BALTIMORE · 2024 · $376,294

## Abstract

PROJECT SUMMARY
Cancer-related fatigue is one of the most common and debilitating toxicities/side effects stemming from cancer
and its treatments. Patients who endure hematologic malignancies are disproportionately affected. There are
few effective treatments for cancer-related fatigue in part because its underlying etiology and pathophysiology
are not well understood. However, disruption of circadian rhythm and dysregulation of glucose metabolism are
two related mechanisms that possibly underlie cancer-related fatigue. Time-restricted eating is a daily eating
pattern that entails consuming food within a defined, consistent window (e.g., 10 h) every day. When the eating
window aligns with the daylight hours, it strongly entrains circadian processes and modulates physiological
regulation of whole-body metabolism. It is hypothesized that time-restricted eating can relieve cancer-related
fatigue in blood cancer survivors via regulating circadian rhythm and improving metabolism. 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 control, unrestricted feeding arm on cancer-related fatigue; follow-up at 24
weeks is also planned. A total of 96 blood cancer survivors will be recruited; eligible survivors will be 2 months
to 2 years post-curative treatment, suffer from moderate to severe fatigue, consume food within a window that
is >10 h, and not be employed away from the home at night. They will be randomized 1:1, intervention: control.
All participants will meet with a nutritionist and discuss nutrition guidelines for cancer survivors; those in the
intervention group will self-select a 10-hour eating window in which to meet the guidelines. At baseline, 6 weeks,
and 12 weeks (post-intervention), we will assess patient-reported fatigue, measures of circadian activity rhythm
(via an activity tracker) and glucose metabolism via continuous glucose monitoring. Participants will log their
food intake using the myCircadianClock smartphone app at baseline and throughout the 12-week study. Aim 1
is to provide initial estimates of efficacy of the 12-week time-restricted eating intervention vs. an unrestricted
eating pattern on patient-reported fatigue. Aim 2 is to assess maintenance of the dietary pattern and sustainability
of any changes in fatigue at 24 weeks. Mechanistic aims assess the effects of time-restricted eating on circadian
rest-activity rhythm (mesor, amplitude, and acrophase) and glucose metabolism (fasting blood glucose, average
blood glucose, glucose excursions), specifically exploring: 1) the associations between changes in circadian
rhythms, glucose metabolism, and fatigue from baseline to post-intervention, and 2) the associations between
adherence to the intervention and changes in circadian rhythm, glucose metabolism, and fatigue. The time-
restricted eating intervention is scalable and inexpensive, lending itself to be ac...

## Key facts

- **NIH application ID:** 10978430
- **Project number:** 1R01CA284082-01A1
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Amber Simmons Kleckner
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $376,294
- **Award type:** 1
- **Project period:** 2024-09-06 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10978430

## Citation

> US National Institutes of Health, RePORTER application 10978430, Time-restricted eating to address cancer-related fatigue among survivors of hematological malignancies (1R01CA284082-01A1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10978430. Licensed CC0.

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