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Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

Primary Purpose

Neoplasms, Therapy, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time-restricted eating
Healthy lifestyle education
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Maryland, BaltimoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Time-restricted eating

Control

Arm Description

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.

Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.

Outcomes

Primary Outcome Measures

Feasibility, as assessed by the percentage of participants who enrolled completed the study
To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
Fatigue, as assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire
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, and a higher score indicates less fatigue.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2022
Last Updated
May 16, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05256888
Brief Title
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
Official Title
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue: The Fatigue REDuction After Cancer (FREDA) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Therapy, Fatigue, Diet Therapy, Time, Survivorship, Fasting, Intermittent

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-restricted eating
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating
Intervention Description
12 weeks of time-restricted eating (10-hour window)
Intervention Type
Behavioral
Intervention Name(s)
Healthy lifestyle education
Intervention Description
Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
Primary Outcome Measure Information:
Title
Feasibility, as assessed by the percentage of participants who enrolled completed the study
Description
To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
Time Frame
12 weeks
Title
Fatigue, as assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire
Description
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, and a higher score indicates less fatigue.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Kleckner, PhD
Phone
4107065961
Email
amber.kleckner@umaryland.edu
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Kleckner, PhD
Phone
410-706-5961
Email
amber.kleckner@umaryland.edu

12. IPD Sharing Statement

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Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

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