Intermittent Fasting for Breast Cancer

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must be taking: Adjuvant endocrine therapy

Must not be taking: Ozempic

Disqualifiers: Diabetes, Eating disorders, Cardiac disease, 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)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that cause dizziness, low blood sugar, or low blood pressure, your eligibility will be evaluated by your doctor.

What data supports the effectiveness of intermittent fasting as a treatment for breast cancer?

Research suggests that intermittent fasting during chemotherapy may protect healthy cells and make cancer cells more vulnerable, potentially improving treatment effectiveness and reducing side effects. Some studies also indicate that fasting might enhance the effectiveness of hormone therapy for certain types of breast cancer. ^{1 2 3 4 5}

Is intermittent fasting safe for humans?

Research suggests that intermittent fasting, including alternate-day fasting, is generally safe for humans and can lead to weight loss and improved health markers like cholesterol and triglycerides. However, some studies have raised concerns about potential adverse events and eating disorder symptoms, so it's important to monitor these aspects during fasting. ^{1 3 6 7 8}

How does intermittent fasting differ from other treatments for breast cancer?

Intermittent fasting is unique because it involves periods of not eating, which may protect healthy cells and make cancer cells more vulnerable during chemotherapy, potentially reducing side effects and improving quality of life. Unlike traditional treatments, it focuses on dietary patterns rather than medication or surgery. ^{1 3 4 6 9}

What is the purpose of this trial?

This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET).

Research Team

Sailaja Kamaraju

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for women over 18 with HR+/HER2- early breast cancer who are starting or already on adjuvant endocrine therapy. They must have a BMI of at least 25 and be willing to follow a specific intermittent fasting schedule. Participants should not be pregnant, breastfeeding, or planning to conceive during the study. Those with certain health conditions like diabetes, eating disorders, or uncontrolled heart disease cannot join.

Inclusion Criteria

You are overweight, with a BMI of 25 or higher.

My doctor has checked my medications for side effects like dizziness or low blood sugar.

Premenopausal woman: Premenopausal is defined as someone who has had menses at any time in the last 12 months. For premenopausal women who are eligible for this trial, the treating physician may choose to monitor ovarian function with laboratory tests e.g., follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol as clinically indicated to assess their menopausal status; Subjects must agree not to conceive throughout the study and must use accepted methods of contraception; Women of childbearing potential must have a negative pregnancy test within seven days of registration and or seven to 10 days prior to starting study treatment; Subjects who have an atypical sleep-wake schedule or different eating schedules are eligible at the discretion of the study investigators and dietitians as long as they agree to nightly fasting; Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

You work late at night.

My doctor has confirmed I have a serious illness or disease.

I have been on a diet or used medication for weight loss in the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intermittent Fasting Intervention

Participants adhere to a daily recurring fourteen-hour nightly fasting period for six months while on adjuvant endocrine therapy

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Intermittent Fasting

Trial Overview The trial is testing if a six-month intermittent fasting program can improve quality of life and reduce inflammation in women undergoing treatment for early-stage breast cancer. It's designed to see if patients can stick to the fasting routine and how it affects their well-being while they're also taking hormone therapy.

Participant Groups

Group I: Intermittent Fasting Experimental Treatment 1 Intervention

Enrolled subjects are expected to start the study intervention after completion of definitive therapy and within three months of starting AET.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

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]

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]

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]

Intermittent fasting (IF) during chemotherapy for breast cancer patients was found to be feasible and safe, potentially alleviating chemotherapy-induced adverse effects like fatigue and nausea, although the quality of the data was low.

While IF showed some promise in reducing chemotherapy-induced DNA damage and improving glycemic regulation, the review did not find significant benefits on quality of life or tumor recurrence, indicating that more rigorous studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting in Breast Cancer: A Systematic Review and Critical Update of Available Studies. Anemoulis, M., Vlastos, A., Kachtsidis, V., et al.[2023]

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]

Modified alternate-day fasting (ADF) significantly reduces cell proliferation rates in various tissues, regardless of whether the diet is low-fat or high-fat, suggesting its potential as a cancer prevention strategy.

In a 4-week study with male mice, both ADF groups showed similar reductions in T-cell proliferation and decreased plasma insulin-like growth factor-1 levels, indicating that ADF can be effective across different dietary fat intakes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. Varady, KA., Roohk, DJ., Bruss, M., et al.[2009]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

Intermittent fasting, particularly alternate-day fasting, has been shown to effectively reduce body weight by approximately 3%-7% and body fat by about 3-5.5 kg over periods of 3 to 12 weeks in various populations, including normal-weight, overweight, and obese individuals.

Whole-day fasting lasting 12 to 24 weeks also leads to significant reductions in body weight (≈3%-9%) and improvements in blood lipids, with total cholesterol decreasing by 5%-20% and triglycerides by 17%-50%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intermittent fasting on body composition and clinical health markers in humans. Tinsley, GM., La Bounty, PM.[2018]

Habitual continuous energy restriction (CER) has been shown to effectively prevent breast tumor formation in both animal studies and observational studies in women, while intermittent energy restriction (IER) and intermittent fasting (IF) may offer easier and potentially more effective alternatives for weight control and cancer prevention.

Animal studies suggest that IER and IF can reduce mammary tumor formation and may have different mechanisms of action compared to CER, including greater reductions in fat stores and improved insulin sensitivity, but more research is needed to directly compare these methods in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. Harvie, M., Howell, A.[2013]

References

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

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

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

Fasting May Complement Endocrine Therapy. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Fasting in Breast Cancer: A Systematic Review and Critical Update of Available Studies. [2023]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. [2009]

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

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

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

Effects of intermittent fasting on body composition and clinical health markers in humans. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. [2013]