Time Restricted Eating for Breast Cancer

KG
Overseen ByKelsey Gabel, RD, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (consuming all meals within an 8-hour window) can benefit individuals undergoing chemotherapy for breast cancer. Researchers aim to determine if this eating plan is feasible and acceptable for those beginning chemotherapy. Participants will follow one of three different 8-hour eating windows or continue with standard care for 24 weeks. The trial seeks individuals with breast cancer who are starting chemotherapy and have not experienced significant weight changes recently or have certain health conditions like diabetes or heart issues. As a Phase 1 trial, the research focuses on understanding how this eating plan affects participants, offering them the chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that time restricted eating is safe for individuals receiving chemotherapy for breast cancer?

Research shows that time-restricted eating (TRE), where all meals occur within an 8-hour period each day, is generally safe for people with cancer. Early results suggest that TRE is not only feasible and acceptable but may also offer benefits during cancer treatment, such as improving quality of life. One study found that following a 16:8 TRE schedule (16 hours of fasting, 8 hours of eating) for 8 weeks was very manageable and safe for older breast cancer survivors. While specific side effects have not been detailed, these studies suggest that TRE is well-tolerated during cancer treatment.12345

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for breast cancer because it offers a fresh approach to managing the disease by focusing on when you eat rather than what you eat. Unlike traditional treatments like chemotherapy, radiation, or hormone therapy that target cancer cells directly, TRE leverages the body's natural rhythms to potentially impact cancer progression. By confining eating to an 8-hour window and fasting for the remaining 16 hours, TRE might help regulate metabolism and reduce inflammation, which could play a role in slowing down cancer growth. This method is non-invasive and doesn't involve medication, offering a promising complementary strategy alongside standard cancer care.

What evidence suggests that time restricted eating might be an effective treatment for breast cancer?

This trial will compare time-restricted eating (TRE) with standard care for breast cancer. Research has shown that TRE might help fight breast cancer. Specifically, studies have found that women who fast for at least 13 hours overnight have a lower chance of breast cancer recurrence. TRE can improve how the body processes food and other functions that may influence cancer growth. This method might also benefit those undergoing chemotherapy. Overall, TRE is gaining attention for its potential to aid cancer treatment and enhance general health.56789

Are You a Good Fit for This Trial?

This trial is for individuals with breast cancer stages I-IV who are starting chemotherapy. It aims to explore the feasibility and acceptability of time-restricted eating, where participants eat all their food within an 8-hour window. The study will compare three different eating schedules against a control group over a period of 24 weeks.

Inclusion Criteria

Able to provide written informed consent and HIPAA authorization for release of personal health information via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization
I can follow the study's procedures for its duration.
All screening labs obtained within 30 days prior to registration
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Exclusion Criteria

Enrolled participants with significant weight loss or weight gain within 3 months of the study (weight gain or loss >4kg)
I do not have uncontrolled HIV/AIDS or active hepatitis.
I have been diagnosed with congestive heart failure.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo chemotherapy while following a time restricted eating protocol for 24 weeks

24 weeks
Regular visits for chemotherapy and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Time Restricted Eating

Trial Overview

The intervention being tested is time-restricted eating during chemotherapy for breast cancer. Participants will be assigned to one of three different eating windows or a control group without restrictions, to see if this dietary approach can benefit those undergoing treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: 8-h TREExperimental Treatment1 Intervention
Group II: Standard Care controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Citations

The Clinical Impact of Time-restricted Eating on Cancer - PMC

Specifically, women who fasted for less than 13 hours per night were at increased risk of breast cancer recurrence compared with women who ...

Time Restricted Eating for the Improvement of Outcomes in ...

This phase II trial studies whether time restricted eating (TRE) works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy ...

Time-restricted eating and cancer: lessons learned and ...

In 2020, the National Cancer Institute (NCI) challenged scientists to determine if intermittent fasting, including time-restricted eating, improved metabolic ...

Time-Restricted Eating: A Novel and Simple Dietary ... - PMC

TRE directly improves many of the biological and behavioral mechanisms underpinning the development of breast cancer and cardiovascular disease.

Time Restricted Eating During Chemotherapy for Breast ...

The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, ...

Time-restricted eating and cancer: lessons learned and ... - PMC

Full achievement of the potential of time-restricted eating would lead to decreased metabolic dysfunction, with a reduction in cancer risk and increased ...

Clinical Impact of Time-restricted Eating on Cancer

Preliminary findings suggest that TRE is feasible and acceptable by people with cancer, may have oncological benefits, and improves quality of life.

Time Restricted Eating During Chemotherapy for Breast ...

The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related ...

Abstract 12484: Weekday 16:8 Time-Restricted Eating in ...

Eight weeks of weekday 16:8 TRE is highly feasible, safe, and reduces CVD risk among older breast cancer survivors with overweight/obesity at moderate CVD risk.