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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Prolonged Nightly Fasting (PNF) and health education might affect health outcomes and recovery in breast cancer patients and survivors. Participants will either follow PNF with health education or receive only health education materials. The trial seeks individuals who have had breast cancer, completed chemotherapy treatment at least three months ago, and are ready to participate fully.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve recovery strategies for breast cancer survivors.

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.

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

Research suggests that fasting for 13 hours or more at night might improve cancer outcomes. Studies have shown that this practice may lower the risk of breast cancer recurrence, making it potentially beneficial for breast cancer patients and survivors.

Regarding safety, this type of fasting is generally well-tolerated. Research involving both humans and animals indicates that it doesn’t usually cause significant health problems. It mainly involves adjusting meal times to extend the fasting period overnight. The studies reviewed have not specifically linked any major harmful effects to this fasting method.

Overall, this approach could be a simple and safe way to support health in breast cancer patients. However, consulting a doctor before changing eating habits is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prolonged nightly fasting as a potential approach for breast cancer management because it offers a unique, non-invasive method that focuses on lifestyle modification rather than medication or surgery. Unlike traditional treatments like chemotherapy or hormonal therapy that often come with significant side effects, prolonged nightly fasting aims to improve metabolic health and may enhance the body's natural ability to fight cancer. This method could also empower patients by giving them an active role in their treatment through dietary management.

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

Research has shown that Prolonged Nightly Fasting (PNF) might aid breast cancer patients in better recovery. Studies suggest that fasting for 13 hours or more each night could reduce the risk of breast cancer recurrence. Specifically, one study found that longer nighttime fasting is linked to a lower chance of cancer returning. Although not all studies find a strong link, early results indicate it could be a promising way to improve health after breast cancer. In this trial, some participants will receive both the Prolonged Nightly Fasting and Health Education Video interventions, while others will participate only in the Health Education Video intervention. These findings highlight the potential benefits of PNF for those recovering from breast cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Sarah James, MD, PhD

Principal Investigator

Mayo Clinic

Dorothy Sears, PhD

Principal Investigator

Arizona State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27032109/

Prolonged Nightly Fasting and Breast Cancer Prognosis Nightly fasting less than 13 hours was not associated with a statistically significant higher risk of breast cancer mortality (hazard ratio, ...

3. facingourrisk.org facingourrisk.org/XRAY/fasting-and-recurrence

XRAY: Can long periods of fasting protect against breast ... A new study associates prolonged fasting (13 hours or more) at night with a lower risk of breast cancer recurrence, but no association between fasting time at ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04330339

Prolonged Nightly Fasting in Breast Cancer Survivors This study is being done to examine whether fasting for 13 hours every night is feasible and if it can help breast cancer survivors lose weight and improve ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.941477/full

Association of time of breakfast and nighttime fasting ... A prospective cohort study showed that elongating the nighttime fasting period could reduce breast cancer recurrence (11).

6. healio.com healio.com/news/hematology-oncology/20160331/prolonged-nightly-fasting-may-reduce-breast-cancer-recurrence-risk

Prolonged nightly fasting may reduce breast cancer ... Fasting for fewer than 13 hours per night may increase the risk for disease recurrence in women with early-stage breast cancer, according to ...