Fasting Intervention for Ovarian Cancer

(FAST Trial)

Overseen By Juan Avitia, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Insulin, Anticoagulants

Disqualifiers: Diabetes, Myocardial infarction, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 4 6 7}

How 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. ^{2 3 4 8 9}

Research Team

Jenna Marcus, MD

Principal Investigator

Northwestern University

Eligibility 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.

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.

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

Treatment Details

Interventions

• FAST Intervention

Trial Overview 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.

Participant Groups

Group I: FAST Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

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]

Short-term fasting (STF) during chemotherapy for gynecological cancer patients was found to be well tolerated and associated with a smaller reduction in quality of life (QOL) compared to non-fasted periods, suggesting potential benefits for patient well-being.

In a pilot trial involving 34 patients, those who fasted experienced less fatigue and a less significant decline in QOL during chemotherapy, indicating that STF may be a promising adjunctive strategy to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bauersfeld, SP., Kessler, CS., Wischnewsky, M., et al.[2021]

Intermittent fasting (IF) significantly reduces tumor-promoting factors and enhances anti-tumor immunity in mice with epithelial ovarian cancer (EOC), leading to improved survival rates.

IF increases the presence of immune cells like CD4+ and CD8+ T cells, enhancing their ability to fight tumors, and produces the metabolite BHB, which also shows anti-tumor effects, although IF is more effective than BHB alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting induced ketogenesis inhibits mouse epithelial ovarian tumors by promoting anti-tumor T cell response. Udumula, MP., Singh, H., Faraz, R., et al.[2023]

In a study using mice with epithelial ovarian cancer (EOC), 16-hour intermittent fasting (IF) was found to significantly inhibit tumor growth and enhance anti-cancer immune responses by increasing key immune cells and creating an unfavorable environment for tumors.

The study revealed that β-hydroxy butyrate (BHB), a metabolite produced during IF, mimics some anticancer effects of fasting, but IF was more effective in improving survival and immune response, likely due to its role in promoting ketogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting induced ketogenesis inhibits mouse epithelial ovarian cancer by promoting antitumor T cell response. Udumula, MP., Singh, H., Rashid, F., 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]

In a phase Ib trial involving 101 patients with advanced cancer, cyclic fasting-mimicking diets (FMDs) were found to be safe and feasible when combined with standard cancer treatments, showing positive metabolic and immunologic changes.

Remarkably, five patients with poor prognosis solid tumors achieved complete and long-lasting tumor remissions, suggesting that cyclic FMD may enhance the effectiveness of standard anticancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. Ligorio, F., Fucà, G., Provenzano, L., et al.[2022]

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]

In a phase II study involving 129 patients with HER2-negative breast cancer, a fasting mimicking diet (FMD) improved patients' perceptions of chemotherapy side effects and overall quality of life compared to a regular diet.

Patients adhering to the FMD reported better emotional, physical, and social functioning, along with lower levels of fatigue, nausea, and insomnia, suggesting that FMD may enhance the supportive care during neoadjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lugtenberg, RT., de Groot, S., Kaptein, AA., et al.[2021]

Fasting may serve as a promising anticancer strategy by enhancing the survival of normal cells while potentially killing cancer cells, supported by nonclinical evidence showing it can reduce chemotherapy toxicity and improve its effectiveness.

Current clinical research on fasting as an adjunct to chemotherapy is encouraging but still in early stages, highlighting the need for personalized approaches and further studies to establish safety and efficacy through large randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Far Are We from Prescribing Fasting as Anticancer Medicine? Deligiorgi, MV., Liapi, C., Trafalis, DT.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

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]

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

Intermittent Fasting induced ketogenesis inhibits mouse epithelial ovarian tumors by promoting anti-tumor T cell response. [2023]

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

Intermittent fasting induced ketogenesis inhibits mouse epithelial ovarian cancer by promoting antitumor T cell response. [2023]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. [2022]

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

Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

How Far Are We from Prescribing Fasting as Anticancer Medicine? [2021]