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

Trial Summary

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.

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 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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{3 10 11 12 13}

Research Team

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.

Exclusion Criteria

Pregnant or nursing

I have had a stroke.

I have been diagnosed with congestive heart failure.

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

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+

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.

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

A review of fasting effects on the response of cancer to chemotherapy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effect of fasting on cancer: A narrative review of scientific evidence. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Fasting and Caloric Restriction in Cancer Prevention and Treatment. [2020]

6. England 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Germany 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating in Breast Cancer Survivors: Effects on Body Composition and Nutritional Status. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]

12. England 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. [2021]

13. United States 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. [2023]