Prolonged Nightly Fasting for Breast Cancer

(RESTORE Trial)

Overseen By Jen Project Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Memory enhancers

Disqualifiers: Type 1 diabetes, Eating disorder, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

Trial Summary

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

The trial information does not specify if you need to stop taking your current medications. However, it does exclude those using memory enhancing medications, so you may need to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Prolonged Nightly Fasting for Breast Cancer?

Research suggests that periodic fasting can enhance the effectiveness of cancer treatments by reducing factors like insulin and IGF1, which are linked to cancer growth. Additionally, studies in mice show that time-restricted feeding can reduce tumor growth, indicating potential benefits for breast cancer patients. ^{1 2 3 4 5}

Is prolonged nightly fasting safe for humans?

Research suggests that prolonged nightly fasting is generally safe for humans, as it has been studied in breast cancer patients and shown to potentially enhance the effectiveness of cancer treatments without significant safety concerns. ^{1 2 4 5 6}

How does the treatment of prolonged nightly fasting differ from other treatments for breast cancer?

Prolonged nightly fasting is unique because it involves not eating for an extended period each night, which may positively influence cancer risk and prognosis by aligning with natural sleep-wake cycles. Unlike traditional treatments like chemotherapy or hormone therapy, this approach focuses on dietary timing rather than medication or surgery. ^{2 4 5 7 8}

What is the purpose of this trial?

The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.

Research Team

Dorothy Sears, PhD

Principal Investigator

Arizona State University

Sarah James, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for English-speaking female breast cancer survivors in the U.S., over 18 years old, who are at least 3 months post-chemotherapy. Participants should have cognitive function concerns (score ≤30 on sr-CRCI), access to a computer with Wi-Fi, and not be on memory meds, have CNS diseases, eating disorders, severe depression or other major health issues.

Inclusion Criteria

Score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI)

Able to speak/understand English

Have access to a computer and Wi-Fi

Exclusion Criteria

I have used memory enhancing drugs before or am currently using them.

I have an active brain or central nervous system condition.

Eating disorder history

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week intervention of Prolonged Nightly Fasting (PNF) or Health Education Only (HED-Only)

8 weeks

Remote participation

Follow-up

Participants are monitored for changes in cognitive function, sleep, insomnia, and quality of life

4 weeks

Treatment Details

Interventions

• Health Education Videos
• Prolonged Nightly Fasting

Trial Overview The study examines if Prolonged Nightly Fasting (PNF) and health education videos can improve sleep quality, cognition, and overall well-being in breast cancer survivors. It's designed to see how these interventions aid in recovery after cancer treatment.

Participant Groups

Group I: Prolonged Nightly Fasting and Health Education Videos Experimental Treatment 2 Interventions

Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions.

Group II: Health Education Videos Only Active Control 1 Intervention

Participants in the Health Education Only condition will participate in only the Health Education Video intervention. Investigators will provide materials about Prolonged Nightly Fasting to these participants at the end of the study.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Findings from Research

Periodic fasting enhances the effectiveness of endocrine treatments for hormone receptor-positive breast cancer by increasing their anti-cancer activity.

Fasting may help delay the development of resistance to these treatments by lowering levels of blood leptin, insulin, and insulin-like growth factor 1 (IGF1), suggesting a potential new strategy for improving breast cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility. Caffa, I., Nencioni, A.[2021]

In a study of 2413 women with early-stage breast cancer, those who fasted for less than 13 hours per night had a 36% higher risk of breast cancer recurrence compared to those who fasted for 13 hours or more, suggesting that longer nightly fasting may help reduce recurrence risk.

Each additional 2 hours of nightly fasting was associated with lower hemoglobin A1c levels and improved sleep duration, indicating that better glucoregulation and sleep may be mechanisms through which nightly fasting influences breast cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged Nightly Fasting and Breast Cancer Prognosis. Marinac, CR., Nelson, SH., Breen, CI., et al.[2022]

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]

Time-restricted feeding during the dark phase significantly reduced the risk of mammary tumor development in mice fed a high-fat diet (HFD), suggesting a protective effect against tumorigenesis.

The study found that while the HFD group had increased body fat and tumor progression, the restricted feeding group maintained body fat levels similar to a standard diet, indicating that timing of food intake may influence metabolic health and cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding mitigates high-fat diet-enhanced mammary tumorigenesis in MMTV-PyMT mice. Sundaram, S., Yan, L.[2019]

A pilot study involving 40 women with a history of early-stage breast cancer showed that prolonged overnight fasting (POF) for 13 hours was feasible, with 95% of participants successfully fasting for at least 70% of the study nights.

Participants experienced significant improvements in anxiety, BMI, depression, and fatigue after 12 weeks of fasting, suggesting that POF may be a beneficial nonpharmacological intervention for improving certain health outcomes in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). O'Donnell, E., Shapiro, Y., Comander, A., et al.[2022]

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]

References

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

Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility. [2021]

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

Prolonged Nightly Fasting and Breast Cancer Prognosis. [2022]

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

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

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

Time-restricted feeding mitigates high-fat diet-enhanced mammary tumorigenesis in MMTV-PyMT mice. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). [2022]

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

Prolonged Nightly Fasting and Breast Cancer Risk: Findings from NHANES (2009-2010). [2022]

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

Plant-Based Diet and IGF-1 Modulation on HER2-Positive Breast Cancer: A Lifestyle Medicine Nutrition Approach in Oncology. [2022]