Intermittent Fasting for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
No Placebo Group
Trial Summary
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).
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.
12345Is 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.
13678How 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.
13469Eligibility 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
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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.
+11 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Intermittent FastingExperimental Treatment1 Intervention
Enrolled subjects are expected to start the study intervention after completion of definitive therapy and within three months of starting AET.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Froedtert Hospital & the Medical College of WisconsinMilwaukee, WI
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. [2022]Preclinical studies prove that short-term fasting secures healthy cells against chemotherapy side effects and makes malignant cells more vulnerable to them. This study aimed to examine the effects of intermittent fasting (IF) during adjuvant chemotherapy AC (doxorubicin, cyclophosphamide) protocol in breast cancer (BC) patients.
Fasting May Complement Endocrine Therapy. [2021]Preliminary findings from a recent study suggest that combining intermittent fasting or a fasting-mimicking diet with endocrine therapy for hormone receptor-positive breast cancer may improve treatment efficacy and reduce side effects.
Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). [2022]Retrospective analysis of nightly fasting among women with breast cancer suggests that fasting
Intermittent Fasting in Breast Cancer: A Systematic Review and Critical Update of Available Studies. [2023]Breast cancer (BC) is the most-frequent malignancy amongst women, whereas obesity and excess caloric consumption increase the risk for developing the disease. The objective of this systematic review was to examine the impact of intermittent fasting (IF) on previously diagnosed BC patients, regarding quality of life (QoL) scores during chemotherapy, chemotherapy-induced toxicity, radiological response and BC recurrence, endocrine-related outcomes, as well as IF-induced adverse effects in these populations. A comprehensive search was conducted between 31 December 2010 and 31 October 2022, using the PubMed, CINAHL, Cochrane, Web of Science, and Scopus databases. Two investigators independently performed abstract screenings, full-text screenings, and data extraction, and the Mixed Method Appraisal Tool (MMAT) was used to evaluate the quality of the selected studies. We screened 468 papers, 10 of which were selected for data synthesis. All patients were female adults whose age ranged between 27 and 78 years. Participants in all studies were women diagnosed with BC of one of the following stages: I, II (HER2-/+), III (HER2-/+), IV, LUMINAL-A, LUMINAL-B (HER2-/+). Notably, IF during chemotherapy was found to be feasible, safe and able to relieve chemotherapy-induced adverse effects and cytotoxicity. IF seemed to improve QoL during chemotherapy, through the reduction of fatigue, nausea and headaches, however data were characterized as low quality. IF was found to reduce chemotherapy-induced DNA damage and augmented optimal glycemic regulation, improving serum glucose, insulin, and IGF-1 concentrations. A remarkable heterogeneity of duration of dietary patterns was observed among available studies. In conclusion, we failed to identify any IF-related beneficial effects on the QoL, response after chemotherapy or related symptoms, as well as measures of tumor recurrence in BC patients. We identified a potential beneficial effect of IF on chemotherapy-induced toxicity, based on markers of DNA and leukocyte damage; however, these results were derived from three studies and require further validation. Further studies with appropriate design and larger sample sizes are warranted to elucidate its potential standard incorporation in daily clinical practice.
Effect of fasting on cancer: A narrative review of scientific evidence. [2022]Emerging evidence suggests that fasting could play a key role in cancer treatment by fostering conditions that limit cancer cells' adaptability, survival, and growth. Fasting could increase the effectiveness of cancer treatments and limit adverse events. Yet, we lack an integrated mechanistic model for how these two complicated systems interact, limiting our ability to understand, prevent, and treat cancer using fasting. Here, we review recent findings at the interface of oncology and fasting metabolism, with an emphasis on human clinical studies of intermittent fasting. We recommend combining prolonged periodic fasting with a standard conventional therapeutic approach to promote cancer-free survival, treatment efficacy and reduce side effects in cancer patients.
Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. [2009]Cell proliferation rates represent a central element in the promotional phase of carcinogenesis. Modified alternate-day fasting (ADF), i.e., a partial 24-h fast alternated with 24-h ad libitum feeding, reduces global cell proliferation rates on a low-fat (LF) diet. Because the majority of Americans consume a diet that is high in fat, testing the antiproliferative ability of ADF on a high-fat (HF) diet is important in terms of diet tolerability in humans. Accordingly, we examined the effects of 85% restriction on the fast day (ADF-85%) with an LF or HF background diet on proliferation rates of various tissues.
Safety of alternate day fasting and effect on disordered eating behaviors. [2018]Alternate day fasting (ADF; ad libitum intake "feed day" alternated with 75% restriction "fast day"), is effective for weight loss, but the safety of the diet has been questioned. Accordingly, this study examined occurrences of adverse events and eating disorder symptoms during ADF.
Effects of intermittent fasting on body composition and clinical health markers in humans. [2018]Intermittent fasting is a broad term that encompasses a variety of programs that manipulate the timing of eating occasions by utilizing short-term fasts in order to improve body composition and overall health. This review examines studies conducted on intermittent fasting programs to determine if they are effective at improving body composition and clinical health markers associated with disease. Intermittent fasting protocols can be grouped into alternate-day fasting, whole-day fasting, and time-restricted feeding. Alternate-day fasting trials of 3 to 12 weeks in duration appear to be effective at reducing body weight (≈3%-7%), body fat (≈3-5.5 kg), total cholesterol (≈10%-21%), and triglycerides (≈14%-42%) in normal-weight, overweight, and obese humans. Whole-day fasting trials lasting 12 to 24 weeks also reduce body weight (≈3%-9%) and body fat, and favorably improve blood lipids (≈5%-20% reduction in total cholesterol and ≈17%-50% reduction in triglycerides). Research on time-restricted feeding is limited, and clear conclusions cannot be made at present. Future studies should examine long-term effects of intermittent fasting and the potential synergistic effects of combining intermittent fasting with exercise.
Energy restriction and the prevention of breast cancer. [2013]Energy restriction (ER) to control weight is a potential strategy for breast cancer prevention. The protective effects of habitual continuous energy restriction (CER) and weight loss on breast tumour formation have been conclusively demonstrated in animal studies over the past 100 years, and more recently in women using data from observational studies and bariatric surgery. Intermittent energy restriction (IER) and intermittent fasting (IF) are possible alternative preventative approaches which may be easier for individuals to undertake and possibly more effective than standard CER. Here, we summarise the available data on CER, IER and IF with special emphasis on their potential for breast cancer prevention. In animals, IER is superior or equivalent to CER with the exception of carcinogen-induced tumour models when initiated soon after carcinogen exposure. There are no human data on IER and breast cancer risk, but three studies demonstrated IER and CER to be equivalent for weight loss. IF regimens also reduce mammary tumour formation in animal models and also led to weight loss in human subjects, but have not been directly compared with CER. Animal and some human data suggest that both IER and IF may differ mechanistically compared with CER and may bring about greater reduction in hepatic and visceral fat stores, insulin-like growth factor 1 (IGF-1) levels and cell proliferation, and increased insulin sensitivity and adiponectin levels. Although IER and IF were first studied 65 years ago, we conclude that further studies are required to assess their values compared with CER.