40 Participants Needed

Time Restricted Eating During Chemotherapy for Breast Cancer

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

Trial Summary

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Time Restricted Eating during chemotherapy for breast cancer?

Research suggests that intermittent fasting, which includes time-restricted eating, may protect healthy cells and make cancer cells more vulnerable during chemotherapy, potentially reducing side effects and enhancing treatment effectiveness.12345

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) is generally considered safe for humans, as studies have shown it is well-tolerated and can improve health-related quality of life, reduce body weight, and improve metabolic health without significant adverse effects.16789

How is time-restricted eating during chemotherapy for breast cancer different from other treatments?

Time-restricted eating (TRE) during chemotherapy for breast cancer is unique because it involves limiting eating to an 8-hour window each day, which may help protect healthy cells and make cancer cells more vulnerable to chemotherapy. This approach is different from traditional treatments as it combines dietary timing with chemotherapy, potentially reducing side effects and improving treatment effectiveness.110111213

What is the purpose of this trial?

Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related outcomes, and limit treatment related weight gain and fat mass accretion.Time restricted eating combined with a mediterranean diet will also be feasible and improve cardiometabolic risk more than TRE alone or standard care.

Research Team

KG

Kelsey Gabel, MS, RD, PhD

Principal Investigator

UIC

Eligibility Criteria

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.

Inclusion Criteria

My blood tests show my organs are working well.
Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines
My breast cancer is confirmed to be at Stage I, II, or III.
See 5 more

Exclusion Criteria

Pregnant or nursing
I have had a stroke.
I have been diagnosed with congestive heart failure.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Treatment

Participants undergo chemotherapy while following either time restricted eating or a Mediterranean diet within an 8-hour window

12 weeks
Regular visits as per chemotherapy schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment, including body composition, treatment side effects, and metabolic markers

4 weeks

Treatment Details

Interventions

  • 8-h time restricted eating
  • MedTRE
  • TRE
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Findings from Research

Intermittent fasting (IF) during chemotherapy for breast cancer patients significantly reduced gastrointestinal toxicity compared to a non-fasting group, suggesting a protective effect of fasting against chemotherapy side effects.
The study, involving 48 HER2-negative breast cancer patients, also indicated that IF improved metabolic profiles, as evidenced by lower insulin levels in the IF group, which may enhance the overall efficacy of chemotherapy.
Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients.Omar, EM., Omran, GA., Mustafa, MF., et al.[2022]
Fasting for up to 5 days may protect cancer patients undergoing chemotherapy by significantly reducing glucose and IGF-I levels, potentially enhancing the body's natural defenses without causing chronic weight loss.
In contrast to long-term calorie restriction, which requires weeks to show effects and can lead to weight loss, fasting offers a quicker and more effective way to improve treatment outcomes for cancer patients, suggesting it could be a valuable clinical intervention.
Fasting vs dietary restriction in cellular protection and cancer treatment: from model organisms to patients.Lee, C., Longo, VD.[2011]
Fasting before or during chemotherapy may enhance the effectiveness of cancer treatments by improving tumor cell responsiveness and protecting normal cells, as suggested by various mechanisms such as DNA repair and increased sensitivity to apoptosis.
While animal and in vitro studies indicate potential benefits of fasting in reducing tumor progression and enhancing chemotherapy efficacy, more human trials are needed to validate these findings due to the limited number of studies available.
A review of fasting effects on the response of cancer to chemotherapy.Sadeghian, M., Rahmani, S., Khalesi, S., et al.[2021]

References

Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. [2022]
Fasting vs dietary restriction in cellular protection and cancer treatment: from model organisms to patients. [2011]
A review of fasting effects on the response of cancer to chemotherapy. [2021]
Effect of fasting on cancer: A narrative review of scientific evidence. [2022]
Fasting and Caloric Restriction in Cancer Prevention and Treatment. [2020]
Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]
Time-Restricted Eating to Improve Cardiovascular Health. [2021]
Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. [2021]
Applicability of time-restricted eating for the prevention of lifestyle-dependent diseases in a working population: results of a pilot study in a pre-post design. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Time-Restricted Eating in Breast Cancer Survivors: Effects on Body Composition and Nutritional Status. [2023]
Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]
Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Adding fasting-mimicking diet to first-line carboplatin-based chemotherapy is associated with better overall survival in advanced triple-negative breast cancer patients: A subanalysis of the NCT03340935 trial. [2023]
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