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Randomized Controlled Trial
. 2025 Apr 5;33(4):353.
doi: 10.1007/s00520-025-09394-w.

Time-restricted eating to address persistent cancer-related fatigue among cancer survivors: a randomized controlled trial

Amber S Kleckner  1   2 , Carin L Clingan  3 , Shari M Youngblood  3   4 , Ian R Kleckner  3   5 , Lauren Quick  3   6 , Rebecca D Elrod  3 , Shijun Zhu  7 , Emily N C Manoogian  8 , Satchidananda Panda  8 , Ashraf Z Badros  5   9 , Ashkan Emadi  5   9   10
Affiliations
Randomized Controlled Trial

Time-restricted eating to address persistent cancer-related fatigue among cancer survivors: a randomized controlled trial

Amber S Kleckner et al. Support Care Cancer. .

Abstract

Purpose: Time-restricted eating (TRE) helps regulate rest-activity rhythms, blood glucose, and other diurnally regulated energetics processes, which may have implications for persistent fatigue. In a randomized controlled trial, we tested the effects of TRE vs. control on fatigue in cancer survivorship.

Methods: Adult cancer survivors were recruited who were 2 months to 2 years post-treatment and reported moderate to severe fatigue. Participants were randomized 1:1, TRE:control, and all received individualized nutrition counseling. The TRE group self-selected a 10-h eating window for 12 weeks. At baseline, week 6, and week 12, participants were asked to log eating instances, complete the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire (FACIT-F, higher score = less fatigue), and wear an actigraph and continuous glucose monitor.

Results: Thirty participants completed baseline assessments and were randomized (77% female, 53% Black/African American, 43% White, 7% Hispanic; 54.1 ± 14.7 years old; 87% with blood cancer); 25 completed 12-week assessments. TRE led to a meaningful reduction in fatigue at week 12 controlling for baseline levels (change in FACIT-F fatigue subscale = 0.0 ± 5.4 for control, 4.1 ± 5.7 for TRE, p = 0.11, effect size (ES) = 0.70; clinically meaningful threshold = 3.0 points). Glucose parameters (e.g., average interstitial glucose, average fasting glucose) tended to be lower, and rest-activity rhythms tended to indicate more regularity for those in the TRE vs. control group at weeks 6 and 12, though differences were not statistically significant (p > 0.19).

Conclusions: A 12-week, nutritionist-led TRE program led to less fatigue than control. Continued study of TRE patterns are warranted to optimize this eating pattern and address persistent cancer-related fatigue.

Trial registration: ClinicalTrials.gov Identifier: NCT05256888.

Keywords: Glucose metabolism; Intermittent fasting; Nutrition; Quality of life; Rest-activity rhythms.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests.

Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials (CONSORT) diagram
Figure 2.
Figure 2.
Fatigue, as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale, over time for those in the time-restricted eating vs. control groups. P-values stem from Analysis of Covariance (ANCOVA) models constructed at week 6 (effect size=0.27) and at week 12 (effect size=0.70) with baseline values as covariates.
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References

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