Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
NCT ID: NCT05256888
Last Updated: 2025-05-07
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2023-01-26
2026-04-30
Brief Summary
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The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Time-restricted eating
Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.
Time-restricted eating
12 weeks of time-restricted eating (10-hour window)
Healthy lifestyle education
Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
Control
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Healthy lifestyle education
Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
Interventions
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Time-restricted eating
12 weeks of time-restricted eating (10-hour window)
Healthy lifestyle education
Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
* Be able to speak and/or read and write in English,
* Be at least 18 years old,
* Own a smartphone,
* Be willing and able to adhere to study procedures, including use of a smartphone app, and
* Be able to provide informed consent.
Exclusion Criteria
* Be underweight, as defined as a body mass index ≤18.5 kg/m2,
* 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.
18 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
University of Maryland, Baltimore
OTHER
Responsible Party
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Amber Kleckner
Assistant Professor
Locations
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University of Maryland, Baltimore
Baltimore, Maryland, United States
Countries
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References
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Kleckner AS, Clingan CL, Youngblood SM, Kleckner IR, Quick L, Elrod RD, Zhu S, Manoogian ENC, Panda S, Badros AZ, Emadi A. Time-restricted eating to address persistent cancer-related fatigue among cancer survivors: a randomized controlled trial. Support Care Cancer. 2025 Apr 5;33(4):353. doi: 10.1007/s00520-025-09394-w.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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HP-00099067
Identifier Type: -
Identifier Source: org_study_id
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