Time Restricted Eating During Chemotherapy for Breast Cancer

Overseen By Kelsey Gabel, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Metastatic disease, Diabetes, BMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how time-restricted eating (eating within an 8-hour window) might benefit women undergoing chemotherapy for breast cancer. It examines whether this eating pattern can enhance treatment effectiveness, reduce side effects, and prevent weight gain. Participants will either follow a time-restricted eating plan, a Mediterranean diet within a time-restricted window, or adhere to current standard care. This trial may suit women with stage I-III breast cancer who have stable weight and no history of eating disorders or night shift work. As an unphased trial, it offers a unique opportunity to investigate innovative dietary strategies that could improve treatment outcomes and quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have examined time-restricted eating (TRE), a form of intermittent fasting, during chemotherapy for breast cancer. These studies show that TRE is generally safe and might even be beneficial. Research suggests that people with cancer find TRE manageable, and it could help improve their quality of life. Importantly, these studies have reported no major safety issues with TRE.

When combined with a Mediterranean diet (MedTRE), TRE also appears safe and practical. This combination might reduce heart health risks more effectively than TRE alone. Again, studies have reported no significant safety problems for MedTRE.

Overall, both TRE and MedTRE seem well-tolerated, with no major adverse events noted in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the time-restricted eating (TRE) approach during chemotherapy for breast cancer because it offers a novel way to potentially enhance treatment outcomes without introducing new drugs. Unlike the standard care that focuses on maintaining calorie and protein intake, TRE involves consuming all food within an 8-hour window each day, which may improve metabolism and reduce side effects. The MedTRE variation combines this timing strategy with a Mediterranean-style diet, known for its anti-inflammatory and heart-healthy benefits. By exploring these dietary strategies, researchers hope to find out if they can improve patients' overall well-being and response to chemotherapy in a simple, non-invasive way.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research shows that time-restricted eating, a type of intermittent fasting, can enhance the effectiveness of chemotherapy for breast cancer. In this trial, participants will follow different eating strategies. One group will practice time-restricted eating, consuming all meals within an 8-hour window. Another group will combine time-restricted eating with a Mediterranean diet, emphasizing fruits, vegetables, and healthy fats. Studies suggest that fasting might reduce treatment side effects and enhance chemotherapy's impact. Early findings indicate that when combined with a Mediterranean diet, it might improve heart health risks more than time-restricted eating alone. Animal studies also support the potential benefits of these eating habits during cancer treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Kelsey Gabel, MS, RD, PhD

Principal Investigator

UIC

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Pregnant or nursing

I have had a stroke.

I have been diagnosed with congestive heart failure.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Time restricted eating Experimental Treatment 1 Intervention

Participants will eat all food within the same self selected 8 hour window daily.

Group II: Med TRE Experimental Treatment 1 Intervention

Participants will eat a mediterranean style diet within the same self selected 8 hour window daily.

Group III: Standard care Active Control 1 Intervention

Current standard care is to eat enough calories and protein to maintain weight and lean mass.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

In a study involving 14 patients with advanced triple-negative breast cancer (aTNBC) undergoing first-line chemotherapy with carboplatin-gemcitabine and cyclic fasting-mimicking diets (FMD), overall survival was significantly improved, with a median survival of 30.3 months compared to 17.2 months for 76 patients receiving chemotherapy alone.

Multivariable analysis confirmed that the use of cyclic FMD was associated with better overall survival, suggesting that combining FMD with chemotherapy may enhance treatment efficacy and warrant further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.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. Ligorio, F., Lobefaro, R., Fucà, G., et al.[2023]

Fasting may enhance cancer treatment effectiveness and reduce side effects by creating conditions that hinder cancer cell survival and growth, as suggested by emerging evidence.

The review emphasizes the need for an integrated understanding of how fasting interacts with cancer therapies, recommending the combination of prolonged periodic fasting with standard treatments to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fasting on cancer: A narrative review of scientific evidence. Tiwari, S., Sapkota, N., Han, Z.[2022]

In an 8-week study involving 22 women over 60 who completed chemotherapy for breast cancer, time-restricted eating (TRE) led to significant reductions in body weight and total fat mass, indicating its potential efficacy for improving body composition.

Bioelectrical impedance vector analysis (BIVA) revealed that while most participants had low phase angles indicating poorer cell integrity, TRE still resulted in favorable changes in body composition for those with obesity, suggesting it may enhance nutritional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating in Breast Cancer Survivors: Effects on Body Composition and Nutritional Status. Da Silva, BR., Kirkham, AA., Ford, KL., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. Omar, EM., Omran, GA., Mustafa, MF., et al.[2022]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of fasting effects on the response of cancer to chemotherapy. Sadeghian, M., Rahmani, S., Khalesi, S., et al.[2021]

A pilot study involving 63 healthy adult employees showed that time-restricted eating (TRE) is feasible and well-accepted, with participants achieving their fasting goals on average 72.2% of the recorded days.

After three months of TRE, participants experienced significant reductions in weight and waist circumference, along with improved health-related quality of life, suggesting that TRE could be a beneficial lifestyle change to combat obesity and related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kesztyüs, D., Vorwieger, E., Schönsteiner, D., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting vs dietary restriction in cellular protection and cancer treatment: from model organisms to patients. Lee, C., Longo, VD.[2011]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

In a study of 131 patients with HER2-negative stage II/III breast cancer, a fasting mimicking diet (FMD) during chemotherapy did not increase toxicity compared to a regular diet, even without the use of dexamethasone.

Patients on the FMD showed significantly better treatment responses, with a higher likelihood of achieving complete or partial tumor response and a greater chance of 90-100% tumor-cell loss, indicating enhanced therapeutic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial. de Groot, S., Lugtenberg, RT., Cohen, D., et al.[2021]

Time-restricted eating (TRE), which limits calorie intake to 6- to 10-hour periods during the active part of the day, has been shown to improve various aspects of metabolic health, including weight loss, glucose tolerance, and cardiovascular health, based on both preclinical and human studies.

Implementing TRE can help mitigate the negative effects of eating out of sync with our body's natural circadian rhythms, potentially reducing the risk of chronic diseases, although there are challenges in applying this dietary approach in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. Regmi, P., Heilbronn, LK.[2021]

Dietary interventions like periodic fasting and fasting-mimicking diets show promise in enhancing the efficacy of cancer therapies and may help prevent cancer, as suggested by preclinical and preliminary clinical studies.

While traditional cancer treatments have remained largely unchanged, emerging dietary strategies could complement these therapies and address the lack of clear nutritional guidelines for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and Caloric Restriction in Cancer Prevention and Treatment. Brandhorst, S., Longo, VD.[2020]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05259410

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10404477/

a randomised controlled trial of the effect of time-restricted ...

A variety of intermittent fasting formats have been examined during chemotherapy for breast cancer and have shown promise as safe interventions with positive ...

3.

academic.oup.com

academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

Clinical Impact of Time-restricted Eating on Cancer

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

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2161831322000837

Current Evidence and Directions for Intermittent Fasting ...

Available data show that periodic fasting, a form of intermittent fasting, may hold potential to improve the effectiveness of chemotherapy, decrease treatment- ...

5.

trialx.com

trialx.com/clinical-trials/listings/281406/time-restricted-eating-during-chemotherapy-for-breast-cancer/

Time Restricted Eating During Chemotherapy for Breast ...

Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12166167/

The 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.

7.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/335121

Time Restricted Eating During Chemotherapy for Breast Cancer

Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05259410?term=AREA%5BConditionSearch%5D(restriction%20dermopathy%20OR%20%22lethal%20hyperkeratosis-contracture%20syndrome%22%20OR%20%22%20lethal%20restrictive%20dermopathy%22%20OR%20%22%20lethal%20tight%20skin-contracture%20syndrome%22%20OR%20%22%20tight%20skin%20contracture%20syndrome%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=4

Time Restricted Eating During Chemotherapy for Breast ...

We aim to test the safety and feasibility of 8-h TRE compared to TRE combined with a mediterranean style diet among female breast cancer patients initiating ...