Fasting for Breast Cancer
(GAMMER Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJennifer Sheng, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Must not be taking: Food-required medications
Disqualifiers: Diabetes, Eating disorder, Uncontrolled conditions, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This research is being done to test the feasibility of 24-48 hours of water-only fasting to improve delivery of 4 cycles of chemotherapy in those receiving breast cancer treatment either before or after surgery.
Will I have to stop taking my current medications?
If you are taking medications that must be taken with food, such as aspirin, lithium, or prednisone, you may need to stop them to participate in this trial. The protocol does not specify other medication restrictions.
What data supports the effectiveness of the treatment Fasting, Intermittent Fasting, Continuous Calorie Energy Reduction (CER), Weight Loss Interventions for breast cancer?
Is fasting safe for humans?
Some studies suggest that intermittent fasting and energy restriction can be safe for humans, as they have been shown to lead to weight loss and improve insulin sensitivity without major side effects in short-term trials. However, more long-term studies are needed to fully understand their safety.34567
How does fasting differ from other treatments for breast cancer?
Fasting, particularly intermittent fasting, is unique because it may enhance the effectiveness of existing breast cancer treatments like chemotherapy and endocrine therapy by making cancer cells more vulnerable and reducing side effects. Unlike traditional treatments, fasting focuses on dietary patterns to potentially improve treatment outcomes and quality of life.23456
Eligibility Criteria
This trial is for individuals undergoing chemotherapy for breast cancer, either before or after surgery. Participants will try water-only fasting for 24-48 hours to see if it helps with the treatment.Inclusion Criteria
Willingness to change diet, and provide fecal sample 3 times during study
Provider physical exam within 4 weeks of consent
BMI ≥ 19.5 kg/m2 (as per most recent visit documented in medical record)
See 3 more
Exclusion Criteria
I have diabetes.
I do not have any severe medical conditions like kidney failure, uncontrolled high blood pressure, or liver cirrhosis.
BMI <19.5 kg/m2
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Finding
Participants undergo a dose finding for fasting, requiring at least one successful 24-hour fast with a maximum of three trials allowed.
1-3 weeks
Up to 3 visits (in-person)
Chemotherapy with Fasting
Participants receive chemotherapy with a fasting regimen, consisting of 4 cycles of chemotherapy with fasting interventions.
8-12 weeks
4 visits (in-person) for chemotherapy cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cytokines, metabolites, and gut microbiome.
6-8 months
Treatment Details
Interventions
- Fasting (Other)
Trial OverviewThe study is testing whether short-term fasting can make chemotherapy more effective in treating breast cancer. Patients will fast for one to two days during their chemo cycles.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Fasting prior to chemotherapyExperimental Treatment1 Intervention
Prior to chemotherapy administration, a trial of a 24-hour water-only fast will be conducted; at least 1 successful 24-hour fast is required to proceed with the fasting intervention during chemotherapy. A total of 3 trials is allowed (for a maximum of 48 hours fasting).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sibley Memorial HospitalWashington, United States
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Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
The Commonwealth FundCollaborator
Maryland Cigarette Restitution FundCollaborator
References
Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility. [2021]We found that periodic fasting increases the anti-cancer activity of endocrine agents used to treat hormone receptor-positive breast cancer and delays acquired resistance to them by reducing blood leptin, insulin and insulin-like growth factor 1 (IGF1). Our work supports further clinical studies of fasting as an adjuvant to endocrine agents in breast cancer patients.
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.
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.
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.
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.
Intermittent energy restriction induces changes in breast gene expression and systemic metabolism. [2022]Observational studies suggest weight loss and energy restriction reduce breast cancer risk. Intermittent energy restriction (IER) reduces weight to the same extent as, or more than equivalent continuous energy restriction (CER) but the effects of IER on normal breast tissue and systemic metabolism as indicators of breast cancer risk are unknown.
Could Intermittent Energy Restriction and Intermittent Fasting Reduce Rates of Cancer in Obese, Overweight, and Normal-Weight Subjects? A Summary of Evidence. [2023]Animal studies and human observational data link energy restriction (ER) to reduced rates of carcinogenesis. Most of these studies have involved continuous energy restriction (CER), but there is increasing public and scientific interest in the potential health and anticancer effects of intermittent energy restriction (IER) or intermittent fasting (IF), which comprise periods of marked ER or total fasting interspersed with periods of normal eating. This review summarizes animal studies that assessed tumor rates with IER and IF compared with CER or ad libitum feed consumption. The relevance of these animal data to human cancer is also considered by summarizing available human studies of the effects of IER or IF compared with CER on cancer biomarkers in obese, overweight, and normal-weight subjects. IER regimens that include periods of ER alternating with ad libitum feed consumption for 1, 2, or 3 wk have been reported to be superior to CER in reducing tumor rates in most spontaneous mice tumor models. Limited human data from short-term studies (≤6 mo) in overweight and obese subjects have shown that IER can lead to greater improvements in insulin sensitivity (homeostasis model assessment) than can CER, with comparable reductions in adipokines and inflammatory markers and minor changes in the insulin-like growth factor axis. There are currently no data comparing IER or IF with CER in normal-weight subjects. The benefits of IER in these short-term trials are of interest, but not sufficient evidence to recommend the use of IER above CER. Longer-term human studies of adherence to and efficacy and safety of IER are required in obese and overweight subjects, as well as normal-weight subjects.