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Behavioral Intervention

Time Restricted Eating During Chemotherapy for Breast Cancer

N/A
Recruiting
Led By Kelsey Gabel, MS, RD, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Demonstrates adequate organ function (absolutely neutrophil count ≥ 1,500/μL)
Breast cancer to meet histologically confirmed Stage I-III
Must not have
Stroke
Congestive heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trialwill study if time-restricted eating can help improve cancer treatment and reduce side effects. #BreastCancer

Who is the study for?
This trial is for women aged 25-99 with Stage I-III breast cancer, who are not pregnant or breastfeeding, do not have severe heart conditions, hepatitis, diabetes, eating disorders, a BMI outside of 25-40kg/m2 range or other major health issues. Participants must be able to follow the study procedures and provide consent.
What is being tested?
The study tests if time restricted eating (TRE), alone or combined with a Mediterranean diet (MedTRE), can improve outcomes of chemotherapy for breast cancer patients. It aims to see if these diets limit weight gain and enhance cardiometabolic health during treatment.
What are the potential side effects?
While specific side effects are not listed for TRE and MedTRE interventions in this context, potential risks may include hunger pangs, fatigue due to calorie restriction, nutritional deficiencies if improperly followed, and psychological stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show my organs are working well.
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My breast cancer is confirmed to be at Stage I, II, or III.
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I am between 25 and 99 years old.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stroke.
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I have been diagnosed with congestive heart failure.
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I have cirrhosis.
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I do not have uncontrolled HIV/AIDS or active hepatitis.
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I have chronic pancreatitis.
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I have had a solid organ transplant.
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I have had a heart attack.
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I have chronic hepatitis.
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I am a woman with either metastatic disease or type 1 or 2 diabetes.
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I have a history of eating disorders.
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I am mentally and physically able to participate in a clinical trial.
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My BMI is between 25 and 40.
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I am currently on medication for an infection.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility 8-h TRE
Secondary study objectives
Body composition
Body weight change
Change in glucose
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted eatingExperimental Treatment1 Intervention
Participants will eat all food within the same self selected 8 hour window daily.
Group II: Med TREExperimental Treatment1 Intervention
Participants will eat a mediterranean style diet within the same self selected 8 hour window daily.
Group III: Standard careActive Control1 Intervention
Current standard care is to eat enough calories and protein to maintain weight and lean mass.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TRE
2023
N/A
~50

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,114 Total Patients Enrolled
12 Trials studying Breast Cancer
1,342,384 Patients Enrolled for Breast Cancer
Kelsey Gabel, MS, RD, PhDPrincipal InvestigatorUIC

Media Library

8-h time restricted eating (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05259410 — N/A
Breast Cancer Research Study Groups: Time restricted eating, Standard care, Med TRE
Breast Cancer Clinical Trial 2023: 8-h time restricted eating Highlights & Side Effects. Trial Name: NCT05259410 — N/A
8-h time restricted eating (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05259410 — N/A
~4 spots leftby Mar 2025
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