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

Trial Summary

What is the purpose of this trial?

This trial studies if intermittent fasting can improve outcomes for breast cancer patients with a BMI of 25 or higher who are receiving chemotherapy. The fasting involves not eating for a certain period and eating during another specific period each day. This approach may help control blood sugar and insulin levels, potentially reducing tumor growth. Intermittent fasting has been studied for its potential benefits in weight loss and managing cardiometabolic risk factors.

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 data supports the effectiveness of the treatment Time Restricted Eating for Breast Cancer?

Research suggests that fasting or time-restricted eating may protect normal cells and improve the effectiveness of chemotherapy by reducing glucose and insulin-like growth factor levels, which cancer cells rely on. Additionally, a fasting-mimicking diet has shown improved clinical response to chemotherapy in breast cancer patients. ^{1 2 3 4 5}

Is time-restricted eating safe for humans undergoing cancer treatment?

Research suggests that short-term fasting or time-restricted eating during chemotherapy is generally safe for humans, with some studies indicating it may reduce side effects like fatigue and gastrointestinal issues. However, more large-scale studies are needed to confirm these findings. ^{1 6 7 8 9}

How does time-restricted eating differ from other treatments for breast cancer?

Time-restricted eating, such as fasting or fasting-mimicking diets, is unique because it may protect healthy cells from chemotherapy's side effects while making cancer cells more vulnerable. Unlike traditional treatments that focus solely on drugs, this approach uses dietary changes to potentially enhance the effectiveness and reduce the toxicity of chemotherapy. ^{2 6 8 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

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

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. [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

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. [2023]

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

Fasting May Complement Endocrine Therapy. [2021]

5. Netherlands 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. [2021]

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Toxicity and efficacy of chronomodulated chemotherapy: a systematic review. [2022]

8. 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]

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

Fasting and cancer treatment in humans: A case series report. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Effects of short-term fasting on cancer treatment. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

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