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Time-Restricted Eating for Cancer-Related Fatigue

N/A

Waitlist Available

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?'

Must not have

Be taking insulin

Be on enteral or parenteral nutrition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking insulin.

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I am receiving nutrition through a feeding tube or IV.

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I am scheduled for surgery during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~850

0 / 5Eligibility criteria met