Fasting Mimicking Diet for Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Immunotherapy

Must not be taking: Insulin

Disqualifiers: Pregnancy, Nursing, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on insulin for diabetes, you will be excluded from the trial.

What data supports the effectiveness of the fasting mimicking diet treatment for cancer?

Research shows that a fasting mimicking diet (FMD) can improve the response to chemotherapy in breast cancer patients and may enhance the effectiveness of various cancer treatments by making cancer cells more sensitive to these therapies. Additionally, FMDs have shown promising results in preclinical models and some clinical trials, suggesting they could help in cancer prevention and treatment. ^{1 2 3 4 5}

Is the Fasting Mimicking Diet generally safe for humans?

Research suggests that the Fasting Mimicking Diet (FMD) is generally safe for humans, as it is a less challenging alternative to water-only fasting and can increase protection in healthy cells while reducing side effects of cancer treatments. ^{1 2 3 5 6}

How does the fasting mimicking diet treatment differ from other cancer treatments?

The fasting mimicking diet (FMD) is unique because it mimics the effects of fasting without requiring complete food abstinence, making it safer and more manageable for cancer patients. It enhances the effectiveness of standard cancer therapies by protecting healthy cells and making cancer cells more vulnerable to treatment, which is different from traditional cancer treatments that often affect both healthy and cancerous cells. ^{1 2 3 4 5}

What is the purpose of this trial?

This clinical trial assesses an effective and translatable care model to understand and reduce the adverse effects that cancer patients experience during their treatment therapies and thereby enhance their well-being and quality of life. Excessive immune activation can affect multiple organs with the most common adverse effects being skin rash, diarrhea, colitis, fatigue, hypothyroidism and anorexia. A restrictive calorie diet, mostly of fat and complex carbohydrates, will mimic fasting and increase resiliency to protect patients from the adverse effects of cancer treatments, by managing the adverse side effects of immune checkpoint inhibitors (ICI) treatments in select cancer patients. The fast mimicking diet (FMD) (Xentigen®) is a calorie restrictive, low-calorie, low-protein, high complex carbohydrate, high-fat diet. The FMD program is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients which are generally regarded as safe (GRAS) and comprises mainly of vegetable-based soups and broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. Following a FMD may reduce the adverse effects that some cancer patients experience while following immunotherapy treatments.

Research Team

Francis A. Farraye, MD, MS

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for cancer patients undergoing immunotherapy who may experience side effects like skin rash, diarrhea, and fatigue. It's suitable for those with specific cancers such as renal cell carcinoma and melanoma. Participants should be willing to follow a special diet mimicking fasting.

Inclusion Criteria

My advanced cancer is suitable for specific immune treatments.

My cancer is confirmed as melanoma, kidney, bladder, or lung cancer.

Exclusion Criteria

My health and weight are stable despite my cancer.

I am under 18 years old.

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutrition counseling and follow a Fasting Mimicking Diet (FMD) over 4 days for 3 cycles of immunotherapy

12 weeks

3 cycles of 4 days each

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood sample collection and symptom assessment

6 months

Treatment Details

Interventions

• Fasting Mimicking Diet

Trial Overview The study tests if a fasting mimicking diet (FMD) can reduce immune-related side effects in cancer patients on immune checkpoint inhibitors. The FMD includes plant-based foods designed to lessen the burden of fasting while providing essential nutrients.

Participant Groups

Group I: Supportive Care (FMD) Experimental Treatment 7 Interventions

Patients receive nutrition counseling with a nutritionist over 60 minutes, receive FMD over 4 days for 3 cycles of immunotherapy and educational guidelines for day 5 to transition to a regular diet. Patients undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

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 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]

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]

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]

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]

Fasting or fasting-mimicking diets (FMDs) can create an environment that makes cancer cells less able to survive and adapt, potentially enhancing the effectiveness of cancer therapies.

FMDs are generally safe and well-tolerated in clinical settings, and they may help protect normal cells from chemotherapy side effects while improving treatment outcomes, making them a promising strategy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and cancer: molecular mechanisms and clinical application. Nencioni, A., Caffa, I., Cortellino, S., et al.[2023]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. [2023]

3. 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]

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

Fasting-mimicking diet: a metabolic approach for the treatment of breast cancer. [2023]

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

Fasting and fasting mimicking diets in cancer prevention and therapy. [2023]

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

Fasting and cancer: molecular mechanisms and clinical application. [2023]