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Time-Restricted Eating for Cancer-Related Fatigue

N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be at least 18 years old
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?'
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will assess if a 12-week intervention of time-restricted eating, or TRF, could help reduce cancer-related fatigue. Participants will be randomly assigned to either the TRF intervention or a control group. The TRF group will select an 10-hour window to consume all food and beverages. The study will also explore if there is a relationship between fatigue, circadian rhythm, and glucose metabolism.

Who is the study for?
This trial is for cancer survivors who are at least 18 years old, have completed their main treatments between 2 months and 2 years ago, can use a smartphone, speak English, and consent to study procedures. They must feel fatigued (score of 4+ on a scale of 0-10) but not be underweight or have conditions like type 1 diabetes that could complicate the diet intervention.Check my eligibility
What is being tested?
The study tests if restricting eating to a 10-hour window each day for 12 weeks reduces fatigue in cancer survivors compared to those receiving general health education. Participants will be randomly assigned to either time-restricted eating or control group in equal numbers.See study design
What are the potential side effects?
Potential side effects may include hunger outside of the eating window, changes in energy levels throughout the day, possible headaches or irritability due to changes in usual eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My worst fatigue level in the last week was 4 or higher on a scale of 0-10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue, as assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire
Feasibility, as assessed by the percentage of participants who enrolled completed the study

Trial Design

2Treatment groups
Experimental Treatment
Group I: Time-restricted eatingExperimental Treatment2 Interventions
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.
Group II: ControlExperimental Treatment1 Intervention
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time-restricted eating
2022
N/A
~520

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
685 Previous Clinical Trials
373,016 Total Patients Enrolled
2 Trials studying Fatigue
107 Patients Enrolled for Fatigue
National Center for Advancing Translational Sciences (NCATS)NIH
319 Previous Clinical Trials
401,701 Total Patients Enrolled

Media Library

Time-restricted eating Clinical Trial Eligibility Overview. Trial Name: NCT05256888 — N/A
Fatigue Clinical Trial 2023: Time-restricted eating Highlights & Side Effects. Trial Name: NCT05256888 — N/A
Time-restricted eating 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256888 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this research program?

"According to clinicaltrials.gov, this particular medical trial is currently seeking qualified participants. It was originally made available on November 1st 2022 and the information has been recently updated on November 15th, 2022."

Answered by AI

What is the enrollment size for this research endeavor?

"Affirmative. Clinicaltrials.gov data implies that this trial is actively recruiting participants, who were first sought after on November 1st 2022 and was most recently updated on the 15th of November 2022. 30 patients are required at a single medical centre for its completion."

Answered by AI
~14 spots leftby Apr 2025