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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special diet plan to help cancer patients feel better during immunotherapy treatments. The diet, known as a Fasting Mimicking Diet (FMD), is low in protein and calories but high in fats and complex carbohydrates. It aims to protect against side effects such as skin rash, fatigue, and stomach issues. Designed to provide similar benefits to fasting while still supplying essential nutrients, the trial seeks patients currently receiving immunotherapy for advanced cancer stages. Candidates with a body mass index over 19 who are not managing diabetes with insulin may be suitable. As an unphased trial, this study offers a unique opportunity to explore innovative dietary approaches to enhance the treatment experience.

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 prior data suggests that the Fasting Mimicking Diet is safe for cancer patients?

Research has shown that the fasting-mimicking diet (FMD) is safe for cancer patients. This diet involves short periods of consuming very few calories and is both feasible and well-tolerated by patients. It includes low-calorie, low-protein meals rich in complex carbohydrates and fats, primarily from plant-based foods like soups, broths, and snacks.

In various studies, patients on the FMD did not experience significant negative effects. The diet is designed to mimic fasting while still providing essential nutrients. This approach may help reduce the side effects of cancer treatments. Overall, FMD appears to be a safe option for managing treatment-related side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard cancer treatments like chemotherapy and radiation, which directly target and destroy cancer cells, the Fasting Mimicking Diet (FMD) offers a unique nutritional approach. Researchers are excited about FMD because it mimics the effects of fasting while allowing patients to still consume certain foods. This diet is thought to potentially enhance the effectiveness of immunotherapy by altering the body's metabolic state, reducing inflammation, and promoting cancer cell stress without the need for drastic calorie restriction.

What evidence suggests that the Fasting Mimicking Diet is effective for reducing adverse effects in cancer patients?

Research shows that a fasting mimicking diet (FMD) can enhance the body's response to cancer treatments. In this trial, participants will receive supportive care with FMD. Studies have found that patients following an FMD experienced improved chemotherapy results, particularly for certain types of breast cancer. This diet also reduces inflammation, potentially easing cancer treatment side effects. Some animal studies demonstrated that FMD increased lifespan and slowed tumor growth. These findings suggest that FMD could ease cancer treatment's impact on the body and improve overall health. ^{2 6 7 8 9}

Who Is on the Research Team?

Francis A. Farraye, MD, MS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

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

Short-term fasting and fasting mimicking diets combined ... An FMD improved the clinical response to neoadjuvant chemotherapy as compared to a regular diet in HER2-negative early breast cancer patients receiving ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1550413124002705

Cyclic fasting-mimicking diet in cancer treatment Fasting/FMD induces broad immunomodulatory effects at both systemic and tumor levels. Indeed, it results in reduced blood proinflammatory ...

3. nature.com nature.com/articles/s41467-024-45260-9

Fasting-mimicking diet causes hepatic and blood markers ... In C57Bl6 mice, when started at middle-age, FMD cycles result in lifespan extension as well as a 45% reduction in tumor incidence and a major ...

4. 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.

5. 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 ...

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

Safety and Feasibility of Fasting-Mimicking Diet and Effects ... In the present phase I/II clinical trial, we showed that periodic FMD cycles were feasible and safe in cancer patients at low nutritional risk ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12396986/

The feasibility and safety of fasting-mimicking diet in breast ... The Fasting-Mimicking Diet (FMD) has emerged as a promising approach for mitigating the side effects and enhancing the efficacy of chemotherapy ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03340935

NCT03340935 | Safety, Feasibility and Metabolic Effects of ... This study aims to assess the safety, feasibility and metabolic effects of the FMD in cancer patients treated with different standard antitumor therapies.

9. aacrjournals.org aacrjournals.org/cancerdiscovery/article/12/1/90/675618/Fasting-Mimicking-Diet-Is-Safe-and-Reshapes

Fasting-Mimicking Diet Is Safe and Reshapes Metabolism and ... Cyclic, severe calorie restriction is safe in patients with cancer, and it reduces blood glucose and growth factor concentration as well as activates.