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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how fasting might help women with ovarian and endometrial cancers feel better during chemotherapy. The study tests whether a specific fasting schedule, known as the FAST Intervention (including methods like Alternate Day Fasting, Time-Restricted Eating, or a Fasting-Mimicking Diet), can reduce chemotherapy's harsh side effects and improve overall quality of life. Participants will either follow a fasting routine or maintain their usual eating habits during treatment. Women diagnosed with ovarian or endometrial cancer, scheduled for chemotherapy, and able to use a smartphone for surveys might be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to explore innovative ways to enhance quality of life during treatment.

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 prior data suggests that this fasting intervention is safe for patients with ovarian and endometrial cancer?

Research has shown that fasting and fasting-like diets are safe for cancer patients. Studies involving various cancer patients suggest these diets might improve health and quality of life by reducing cancer cell survival. Specifically, alternate day fasting has been examined, and results indicate it is well-tolerated. Although specific safety data for fasting in ovarian and endometrial cancer patients is not yet available, existing research supports its safety in a broader range of cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAST intervention for ovarian cancer because it explores a non-traditional approach by incorporating alternate day fasting (ADF) into the treatment plan. Unlike standard chemotherapy treatments, which focus solely on drugs to attack cancer cells, the FAST intervention uses a dietary method that might enhance the effectiveness of chemotherapy. By potentially reducing side effects and improving overall health, this fasting method could offer a complementary strategy to existing treatments, giving patients a holistic approach to managing their cancer.

What evidence suggests that the FAST intervention could be effective for ovarian cancer?

Research has shown that fasting and diets mimicking fasting might aid cancer patients during chemotherapy. Some studies suggest fasting can enhance well-being and reduce inflammation, potentially lessening chemotherapy's side effects. In this trial, participants in the FAST Group will undergo a fasting intervention to explore these potential benefits. Although the effects of fasting on ovarian and endometrial cancers are not fully understood, early results appear promising. The aim is to make treatments more manageable without adding extra risks. However, more research is necessary to confirm these benefits specifically for ovarian and endometrial cancer patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Jenna Marcus, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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

You work night shifts or late shifts.

Patients whose oncologist has not provided clearance for their participation

I have had cancer treatment within the last 2 years.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10037739/

Short-term fasting and fasting mimicking diets combined ...

In this narrative review, we identify and describe the current evidence about feasibility and effects of STF and FMDs in cancer patients receiving chemotherapy.

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sciencedirect.com

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Fasting and fasting mimicking diets in cancer prevention ...

Fasting mimicking diets (FMDs) are emerging as effective dietary interventions with the potential to improve healthspan and decrease the incidence of cancer.

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Impact of Fast-Mimicking Diet and Fasting Dietary ...

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There is no data specifically addressing the impact of a fasting diet regimen on side effects of chemotherapy during treatment for ovarian and endometrial ...

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withpower.com

withpower.com/trial/phase-deficiency-calorie-8-2021-6c0f9

Fasting Mimicking Diet for Ovarian Cancer

Fasting or a fasting-mimicking diet (FMD) can slow down tumor growth but does not enhance the sensitivity of colorectal cancer (CRC) cells to chemotherapy drugs ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9530862/

Effect of fasting on cancer: A narrative review of scientific ...

Emerging evidence suggests that fasting could play a key role in cancer treatment by fostering conditions that limit cancer cells' adaptability, survival, and ...