Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue: The Fatigue REDuction After Cancer (FREDA) Trial
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland, Baltimore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
12 weeks of time-restricted eating (10-hour window)
Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
|
Other: Control
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
|
Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study
Time Frame: 12 weeks
|
To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
|
12 weeks
|
|
Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire
Time Frame: 12 weeks
|
FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels.
This questionnaire is 13-items long.
The scale is from 0-52, and a higher score indicates less fatigue.
|
12 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00099067
- UL1TR003098 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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