Active — Not RecruitingNot Applicable

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

United States50 participantsStarted 2023-01-26

Plain-language summary

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism. 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer, including chemotherapy for hematologic neoplasms, at least 2 months and not more than 2 years prior to enrolling, * 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: * Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week, * 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.

What they're measuring

Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study

Timeframe: 12 weeks

Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire

Timeframe: 12 weeks

Trial details

NCT IDNCT05256888

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

Results submitted2025-04-17

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