Fasting Intervention for Ovarian Cancer
(FAST Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJenna Marcus, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Must not be taking: Insulin, Anticoagulants
Disqualifiers: Diabetes, Myocardial infarction, Stroke, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Endometrial cancer is the most common gynecologic cancer and ovarian cancer is the most lethal. The management of both advanced cancers is a combination of chemotherapy and surgery. Standard of care chemotherapeutic treatment for uterine and ovarian cancers is toxic and severely disruptive to the patient's quality of life with the potential for devastating short and long-term side effects. The role of fasting and ketogenic diets has been evaluated in a mixed cancer population and previously shown to be safe. There is no data specifically addressing the impact of a fasting diet regimen on side effects of chemotherapy during treatment for ovarian and endometrial cancers in the front-line setting. The information gathered from this study will inform future trials about the role of time-restricted eating and its impact on side-effects associated with chemotherapy as well as its role in improvement of quality of life for women afflicted with these debilitating diseases.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but if you take medications for conditions like hypertension or electrolyte issues, your doctor will monitor and adjust them as needed during fasting.
What data supports the effectiveness of the fasting intervention treatment for ovarian cancer?
Research on mice with ovarian cancer shows that intermittent fasting can boost the body's immune response against tumors and reduce factors that help tumors grow. This suggests that fasting might help improve cancer treatment effectiveness and support the body's natural defenses.
12345Is fasting safe for humans, especially in the context of cancer treatment?
Research suggests that short-term fasting and fasting-mimicking diets are generally safe for humans, including those undergoing cancer treatment, as they may improve quality of life and enhance the effectiveness of therapies without significant adverse effects.
12467How does fasting intervention differ from other treatments for ovarian cancer?
Fasting intervention is unique because it uses intermittent fasting to create a hostile environment for tumors by reducing growth factors and enhancing the body's immune response against cancer cells. Unlike traditional treatments, it boosts the body's natural defenses and metabolic processes, potentially improving the effectiveness of other cancer therapies.
23489Eligibility Criteria
This trial is for women over 18 with confirmed or suspected endometrial, ovarian, fallopian tube, or primary peritoneal cancer who are fluent in English and have internet access. They must be planning to receive chemotherapy after surgery at Northwestern Medicine and have an ECOG status of 0 or 1.Inclusion Criteria
Willingness to sign informed consent form
Have access to the internet to complete surveys
I am a woman aged 18 or older.
+4 more
Exclusion Criteria
Patients whose oncologist has not provided clearance for their participation
You work night shifts or late shifts.
I have had cancer treatment within the last 2 years.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo chemotherapy with alternate day fasting (ADF) for a total of 6 weeks
6 weeks
Weekly visits for chemotherapy administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Extension
Participants may continue to be monitored for long-term effects and quality of life improvements
8 weeks
Participant Groups
The study tests the effects of alternate day fasting on side effects and quality of life during chemotherapy for gynecologic cancers. It aims to see if this diet regimen can reduce the negative impact of standard chemotherapeutic treatment.
2Treatment groups
Experimental Treatment
Active Control
Group I: FAST GroupExperimental Treatment1 Intervention
The FAST intervention will consist of one week of alternate day fasting (ADF) using the sandwich model at the start of each cycle of chemotherapy, for a total of 6 weeks of ADF. Patients will be instructed on how and what they may consume on fasting days.
Group II: Control GroupActive Control1 Intervention
Participants in the control arm will be instructed to eat as desired throughout their entire chemotherapy treatment course. Control group participants will not receive any special study- related instructions or direction regarding food and drinks consumed during chemotherapy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern Memorial HospitalChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
References
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
The effects of short-term fasting on quality of life and tolerance to chemotherapy in patients with breast and ovarian cancer: a randomized cross-over pilot study. [2021]This pilot trial aimed to study the feasibility and effects on quality of life (QOL) and well-being of short-term fasting (STF) during chemotherapy in patients with gynecological cancer.
Intermittent Fasting induced ketogenesis inhibits mouse epithelial ovarian tumors by promoting anti-tumor T cell response. [2023]Epithelial Ovarian Cancer (EOC) is the most lethal gynecologic cancer with limited genetic alterations identified that can be therapeutically targeted. In tumor bearing mice, short-term fasting, fasting mimicking diet and calorie restriction enhance the activity of antineoplastic treatment by modulating systemic metabolism and boosting anti-tumor immunity. We tested the outcome of sixteen-hour intermittent fasting (IF) on mouse EOC progression with focus on fasting driven antitumor immune responses. IF resulted in consistent decrease of tumor promoting metabolic growth factors and cytokines, recapitulating changes that creates a tumor antagonizing environment. Immune profiling revealed that IF profoundly reshapes anti-cancer immunity by inducing increase in CD4+ and CD8+ cells, paralleled by enhanced antitumor Th1 and cytotoxic responses, by enhancing their metabolic fitness. Metabolic studies revealed that IF generated bioactive metabolite BHB which can be a potential substitute for simulating the antitumor benefits of IF. However, in a direct comparison, IF surpassed exogenous BHB therapy in improving survival and activating anti-tumor immune response. Thus, our data provides strong evidence for IF and its metabolic mediator BHB for ameliorating EOC progression and as a viable approach in maintaining and sustaining an effective anti-tumor T cell response.
Intermittent fasting induced ketogenesis inhibits mouse epithelial ovarian cancer by promoting antitumor T cell response. [2023]In various cancer models, dietary interventions have been shown to inhibit tumor growth, improve anticancer drug efficacy, and enhance immunity, but no such evidence exists for epithelial ovarian cancer (EOC), the most lethal gynecologic cancer. The anticancer immune responses induced by 16-h intermittent fasting (IF) were studied in mice with EOC. IF consistently reduced metabolic growth factors and cytokines that stimulate tumor growth, creating a tumor-hostile environment. Immune profiling showed that IF dramatically alters anti-cancer immunity by increasing CD4+ and CD8+ cells, Th1 and cytotoxic responses, and metabolic fitness. β-hydroxy butyrate (BHB), a bioactive metabolite produced by IF, partially imitates its anticancer effects by inducing CD8+ effector function. In a direct comparison, IF outperformed exogenous BHB treatment in survival and anti-tumor immune response, probably due to increased ketogenesis. Thus, IF and one of its metabolic mediators BHB suppress EOC growth and sustain a potent anti-tumor T cell response.
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.
Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. [2022]Cyclic fasting or calorie-restricted, low-carbohydrate, low-protein diets, collectively referred to as fasting-mimicking diets (FMDs), demonstrated additive or synergistic antitumour effects when combined with chemotherapy, targeted therapies, or immunotherapy in several preclinical in vivo models, including murine models of breast cancer, lung cancer, and colorectal cancer. However, no data on the antitumour efficacy of cyclic FMD in patients with cancer have been published so far. Here, we aim at reporting on patients with advanced cancer achieving complete and long-lasting tumour remissions with cyclic FMD in combination with standard anticancer therapies in the context of the phase Ib NCT03340935 trial.
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.
Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial. [2021]In the phase II DIRECT study a fasting mimicking diet (FMD) improved the clinical response to neoadjuvant chemotherapy as compared to a regular diet. Quality of Life (QoL) and illness perceptions regarding the possible side effects of chemotherapy and the FMD were secondary outcomes of the trial.
How Far Are We from Prescribing Fasting as Anticancer Medicine? [2021](1) Background: the present review provides a comprehensive and up-to date overview of the potential exploitation of fasting as an anticancer strategy. The rationale for this concept is that fasting elicits a differential stress response in the setting of unfavorable conditions, empowering the survival of normal cells, while killing cancer cells. (2) Methods: the present narrative review presents the basic aspects of the hormonal, molecular, and cellular response to fasting, focusing on the interrelationship of fasting with oxidative stress. It also presents nonclinical and clinical evidence concerning the implementation of fasting as adjuvant to chemotherapy, highlighting current challenges and future perspectives. (3) Results: there is ample nonclinical evidence indicating that fasting can mitigate the toxicity of chemotherapy and/or increase the efficacy of chemotherapy. The relevant clinical research is encouraging, albeit still in its infancy. The path forward for implementing fasting in oncology is a personalized approach, entailing counteraction of current challenges, including: (i) patient selection; (ii) fasting patterns; (iii) timeline of fasting and refeeding; (iv) validation of biomarkers for assessment of fasting; and (v) establishment of protocols for patients' monitoring. (4) Conclusion: prescribing fasting as anticancer medicine may not be far away if large randomized clinical trials consolidate its safety and efficacy.