Time Restricted Eating for Breast Cancer

Overseen By Maysa Abu-Kalaf, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: Neoadjuvant chemotherapy

Must not be taking: Insulin, Weight loss medications

Disqualifiers: T4/N3 disease, Diabetes, Eating disorder, Smoking, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (TRE) can benefit individuals with HER2-negative breast cancer who are beginning chemotherapy (cytotoxic therapy). The researchers aim to determine if a 16:8 eating schedule, involving 16 hours of fasting and 8 hours of eating, affects the treatment process. The trial seeks participants recently diagnosed with stage I-III breast cancer, who have a BMI between 25-40, and can adhere to the TRE schedule. This study aims to provide new insights into how eating habits might support cancer treatment. As an unphased trial, it offers the opportunity to contribute to groundbreaking research on dietary habits and cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to ensure it aligns with the trial's requirements and your treatment plan.

What prior data suggests that time restricted eating is safe for patients with breast cancer?

Previous studies have shown promising results for the safety and effectiveness of time-restricted eating (TRE). Research suggests that TRE, which involves eating only during an 8-hour period and fasting for the remaining 16 hours each day, can improve outcomes for breast cancer patients. One study reported that following a 16:8 TRE schedule for 8 weeks was safe and feasible for older breast cancer survivors. Another study found that fasting at certain times during chemotherapy could enhance treatment effectiveness and reduce side effects. This approach appears well-tolerated and might lower the risk of cancer recurrence. While more research is needed, early findings support TRE as a safe option for those undergoing chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) as a complementary approach for breast cancer treatment because it offers a unique way to potentially enhance the effects of chemotherapy. Unlike current standard treatments that focus solely on medication, TRE involves limiting eating to specific hours of the day, which may help in managing cancer cell metabolism and improving the body's response to treatment. This method is non-invasive and could reduce side effects, making it a promising adjunct to traditional chemotherapy regimens. By optimizing the timing of food intake, TRE might offer a novel strategy to boost treatment efficacy without additional medication.

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

Research has shown that eating only during certain hours of the day, known as time-restricted eating (TRE), might enhance the effectiveness of chemotherapy for breast cancer. In this trial, participants will follow TRE for 16 weeks while receiving chemotherapy. Some studies have found that patients experienced less fatigue and nausea when adhering to a fasting schedule. Additionally, fasting has been linked to a reduced risk of cancer recurrence. Animal studies suggest that fasting can improve chemotherapy's effectiveness and lessen its side effects. Overall, early evidence indicates that TRE could be a valuable addition to breast cancer treatment. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage I-III breast cancer and a BMI of at least 25. They must have HER2 negative tumors, low hormone receptor positivity, and be eligible for standard pre-surgery chemotherapy. Patients with small multifocal cancers or limited metastatic disease may also qualify if they're planning to undergo the same chemo.

Inclusion Criteria

My tumor is HER2 negative according to specific guidelines.

My breast tumor is at least 1.5 cm or I have cancer in my underarm lymph nodes.

I have more than one breast cancer spot, all meeting the same ER/PR and HER2 criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in Time Restricted Eating (TRE) while receiving neoadjuvant chemotherapy for 16 weeks

16 weeks

Approximately every 2-3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue TRE if neoadjuvant chemotherapy extends beyond 16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Short-Term Fasting

Trial Overview The study is testing whether intermittent fasting can improve outcomes in patients receiving chemotherapy before surgery for breast cancer. It's based on evidence that fasting might help reduce blood sugar levels, increase insulin sensitivity, and slow down tumor growth.

How Is the Trial Designed?

Group I: Treatment (Time Restricted Eating) Experimental Treatment 1 Intervention

This is a single arm, non-randomized trial. All participants will undergo TRE for 16 weeks while receiving NCT. For patients requiring NCT longer than 16 weeks, they can continue TRE however this will not be included in the main adherence calculations.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Short-term fasting (STF) was well tolerated by patients undergoing chemotherapy for early breast cancer and resulted in significantly higher erythrocyte and thrombocyte counts post-treatment compared to those who did not fast.

STF may help reduce DNA damage in peripheral blood mononuclear cells after chemotherapy, suggesting a protective effect against some of the harmful side effects of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study. de Groot, S., Vreeswijk, MP., Welters, MJ., et al.[2021]

In a study involving 172 women undergoing chemotherapy, intermittent energy restriction (IER) showed a trend towards greater weight and body fat reduction compared to continuous energy restriction (CER), particularly after adjusting for body water.

While the overall incidence of severe chemotherapy toxicities was similar between IER and CER, there was a trend indicating fewer severe toxicities in the IER group during later cycles of treatment, suggesting IER may help reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. Harvie, M., Pegington, M., Howell, SJ., et al.[2022]

Preliminary findings indicate that combining intermittent fasting or a fasting-mimicking diet with endocrine therapy may enhance the effectiveness of treatment for hormone receptor-positive breast cancer.

This combination approach could also help in reducing side effects associated with the endocrine therapy, suggesting a potential strategy for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting May Complement Endocrine Therapy. [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 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]

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]

This study will evaluate the effectiveness of a multimodal intervention combining time-restricted eating, healthy eating, and reduced sedentary time during chemotherapy in 130 women with early-stage breast cancer, focusing on reducing visceral fat accumulation and improving metabolic health.

If successful, the intervention could significantly lower the risk of cardiometabolic diseases and related mortality in breast cancer survivors, highlighting the importance of dietary and lifestyle modifications during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of IMPACT-women: a randomised controlled trial of the effect of time-restricted eating, healthy eating and reduced sedentary behaviour on metabolic health during chemotherapy for early-stage breast cancer. Christensen, RAG., Haykowsky, MJ., Nadler, M., et al.[2023]

In a phase II study involving 129 patients with HER2-negative breast cancer, a fasting mimicking diet (FMD) improved patients' perceptions of chemotherapy side effects and overall quality of life compared to a regular diet.

Patients adhering to the FMD reported better emotional, physical, and social functioning, along with lower levels of fatigue, nausea, and insomnia, suggesting that FMD may enhance the supportive care during neoadjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial. Lugtenberg, RT., de Groot, S., Kaptein, AA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9920353/

Intermittent Fasting in Breast Cancer: A Systematic Review ... A total of 12.5% of patients noted nausea improvement during fasting; 50% reported fatigue improvement during fasting; in 62.5% of patients, fasting made them ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05259410

Time Restricted Eating During Chemotherapy for Breast ... Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. ... outcomes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12229459/

Time-restricted eating and cancer: lessons learned ... In addition to improved HbA1c, prolonged nightly fasting was associated with a statistically significant lower risk of disease recurrence in a cohort of breast ...

4. 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305737224000525

Intermittent fasting and its impact on toxicities, symptoms ... In this review, we examine the impact of intermittent fasting on symptoms, toxicities, and quality of life in patients undergoing cancer therapy and highlight ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4982776/

Prolonged Nightly Fasting and Breast Cancer Prognosis Taken together, the rodent and human data support the hypothesis that a prolonged nightly fasting interval could reduce cancer risk and improve cancer outcomes.

7. ahajournals.org ahajournals.org/doi/10.1161/circ.144.suppl_1.12484

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.