Fasting Mimicking Diet for Ovarian Cancer

Overseen By Min Wei, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: L-Nutra Inc

Must not be taking: Daily medications without food

Disqualifiers: Diabetes, Cardiac disease, Food allergies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special diet called a Fasting Mimicking Diet to determine if it can help manage chemotherapy side effects in women with gynecologic cancers. The study compares this diet plus standard cancer care against standard care alone. Women diagnosed with a gynecologic cancer and undergoing chemotherapy with at least six cycles remaining might be suitable candidates if they are willing to try this diet. The goal is to assess whether the diet can make chemotherapy more tolerable by reducing its side effects. As an unphased trial, this study provides a unique opportunity to explore new ways to improve quality of life during cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you take daily medications that cannot be safely taken without food.

What prior data suggests that the Fasting Mimicking Diet is safe for managing chemotherapy side effects?

Research has shown that the Fasting Mimicking Diet (FMD) is generally safe for people. This diet involves consuming very few calories for short periods. Most individuals experience only mild side effects, maintaining stable weight and strength, with some even seeing improvements in body shape.

Additionally, FMD is considered safe and might help the body fight cancer by affecting metabolism and the immune system. While the diet can have positive effects, individuals should consider their own health needs and consult a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Fasting Mimicking Diet (FMD) is unique because it offers a dietary approach to support ovarian cancer treatment, potentially enhancing the effects of standard therapies like chemotherapy and surgery. Unlike traditional treatments that focus directly on attacking cancer cells, FMD aims to create a body environment that stresses cancer cells while protecting healthy ones through controlled fasting. This method could improve patient outcomes by making cancer cells more vulnerable to existing treatments, all while being a non-invasive and natural addition to the standard care regimen. Researchers are excited about this approach because it opens a new avenue for supporting cancer treatment with minimal side effects.

What evidence suggests that the Fasting Mimicking Diet is effective for managing chemotherapy side effects in ovarian cancer?

Research has shown that a fasting mimicking diet (FMD) might help cancer patients undergoing chemotherapy by reducing side effects. Some studies suggest this diet can improve survival rates and quality of life. It may also decrease inflammation and help the body cope better with chemotherapy. In this trial, participants in the FMD arm will follow a 5-day fasting mimicking diet alongside standard care. The diet involves short periods of very low calorie intake, which studies have found to be safe and possibly beneficial for cancer treatment. While more research is needed, early results are promising for using this diet with standard cancer care. ^{2 3 4 5 6}

Who Is on the Research Team?

Jonathan Boone

Principal Investigator

The University of Tennessee Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with gynecologic cancers such as ovarian cancer, who are undergoing chemotherapy. It's designed to see if a special diet that mimics fasting can help manage the side effects of their treatment.

Inclusion Criteria

I am between 35 and 70 years old.

My cancer diagnosis was confirmed with a biopsy.

I am scheduled for or currently receiving chemotherapy, with at least 6 treatments left.

Exclusion Criteria

I do not have recent severe heart issues, stroke, kidney failure, eating disorders, dementia, psychosis, or mobility problems.

Taking daily medications that cannot be safely taken without food

Pregnant or nursing mothers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy with or without a fasting mimicking diet for 21 weeks

21 weeks

Regular visits aligned with chemotherapy schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fasting Mimicking Diet

Trial Overview The study is testing whether a Fasting Mimicking Diet alongside standard chemotherapy can reduce the negative side effects associated with chemo in patients with gynecologic malignancies.

How Is the Trial Designed?

Group I: FMD Experimental Treatment 2 Interventions

In addition to the standard care, subject will consume a 5-day fasting mimicking diet.

Group II: Control Active Control 1 Intervention

Subjects will receive the standard care and no dietary changes.

Who Is Running the Clinical Trial?

L-Nutra Inc

Lead Sponsor

Trials

10

Recruited

730+

University of Tennessee Medical Center

Collaborator

Trials

7

Recruited

450+

Published Research Related to This Trial

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]

In a study of 496 women with ovarian cancer and 1,425 control women, higher intakes of dietary fiber, vitamins A and E, carotenoids, and total fruit and vegetable consumption were associated with a significantly reduced risk of ovarian cancer.

Conversely, women in the highest quartile of total energy intake showed a weakly increased risk of ovarian cancer, suggesting that a diet rich in plant foods may help lower the risk of this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intakes of selected nutrients and food groups and risk of ovarian cancer. McCann, SE., Moysich, KB., Mettlin, C.[2022]

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 mimicking diets (FMDs) are a safer and more manageable alternative to traditional fasting for cancer patients, potentially improving healthspan and reducing the risk of cancer and age-related diseases.

FMD cycles enhance the effectiveness of various cancer therapies in mice by boosting antitumor immunity and creating conditions that protect healthy cells while making cancer cells more vulnerable to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and fasting mimicking diets in cancer prevention and therapy. Blaževitš, O., Di Tano, M., Longo, VD.[2023]

A study involving 286 women with ovarian cancer revealed that dietary practices after primary treatment vary significantly based on whether they are undergoing further treatment for recurrence or not.

Women receiving treatment for recurrence often followed specific dietary regimens for clinical reasons, while those without recurrence tended to adopt popular diets influenced by personal beliefs and social factors, highlighting the need for better access to evidence-based dietary information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Practices After Primary Treatment for Ovarian Cancer: A Qualitative Analysis From the OPAL Study. Johnston, EA., Ekberg, S., Jennings, B., et al.[2022]

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 like 5-fluorouracil and oxaliplatin, indicating a complex relationship between fasting and cancer treatment.

The study identified that fasting induces CRC cells to enter a slow-cycling state, which may lead to the development of drug-tolerant persister cells that contribute to cancer relapse; however, combining fasting with ferroptosis inducers could enhance tumor inhibition and target these resistant cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. Liu, X., Peng, S., Tang, G., et al.[2023]

Preclinical studies indicate that fasting and fasting-mimicking diets (FMDs) can enhance the effectiveness of chemotherapy and other treatments in breast cancer models, particularly in triple-negative breast cancer (TNBC) and hormone receptor-positive (HR+)/HER2 types.

Clinical experiences show that fasting/FMD is feasible and well tolerated by breast cancer patients undergoing standard treatments, potentially reducing chemotherapy-related side effects, although more rigorous randomized trials are needed to confirm its antitumor efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting-mimicking diet: a metabolic approach for the treatment of breast cancer. Ligorio, F., Provenzano, L., Vernieri, C.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06376604

Study Details | NCT06376604 | Fasting Mimicking Diet in ... This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

2. 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.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006295223002903

Verification of fasting-mimicking diet to assist monotherapy ... Based on these findings, FMD might be a safe and effective auxiliary approach and be worthy of being further investigated to assist nanodrug in cancer therapy.

4. journal.ppcr.org journal.ppcr.org/index.php/ppcrjournal/article/download/349/411

Impact of Fast-Mimicking Diet and Fasting Dietary ... Some studies suggest that fasting may improve overall survival, quality of life (QoL), inflammatory biomarkers, and a decrease in chemotherapy-induced ...

5. aacr.org aacr.org/patients-caregivers/progress-against-cancer/fasting-mimicking-diet-found-safe-and-potentially-helpful-to-cancer-patients/

“Fasting-mimicking” Diet Found Safe and Potentially ... A diet involving short-term, severe calorie restriction was safe and resulted in biological effects in the body that may be helpful in cancer treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8391327/

Safety and Feasibility of Fasting-Mimicking Diet and Effects ... FMD was largely safe with only mild side effects. The patients' weight and handgrip remained stable, the phase angle and fat-free mass increased ...