Caloric Restriction and Plant-Based Diet for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must not be taking: Corticosteroids, Calcitriol

Disqualifiers: ECOG status 2, Infection, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating fewer calories on alternate days can enhance the effectiveness of chemotherapy against cancer. Intermittent caloric restriction might boost chemotherapy's cancer-fighting effects. Suitable participants include those with a confirmed cancer diagnosis who are about to begin chemotherapy. As an unphased trial, this study offers a unique opportunity to contribute to innovative cancer treatment research.

Will I have to stop taking my current medications?

The trial requires that you stop taking systemic corticosteroids and high dose calcitriol (a form of vitamin D) at least 28 days before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fasting and eating fewer calories might be safe and beneficial. For instance, a large study with 2,000 participants found that fasting with only 350 calories a day was safe and even helped with long-term health issues. Other studies suggest that fasting can protect healthy cells while targeting damaged ones, like cancer cells, without major negative side effects.

Regarding plant-based diets, research indicates they might lower the risk of some cancers. One study found that following a healthy plant-based diet was linked to a lower risk of cancer and other diseases. Another study suggested that a plant-based diet could reduce cancer-related deaths.

Overall, these treatments appear safe based on previous research, but individual experiences may vary. It is always best to discuss any treatment plans with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring caloric restriction and a plant-based diet for cancer treatment because these approaches could significantly enhance current strategies. Unlike traditional treatments that often rely heavily on drugs and radiation, these dietary interventions focus on altering the body's metabolic environment to potentially slow cancer growth. By reducing caloric intake and emphasizing plant-based foods, this method aims to weaken cancer cells by limiting their energy supply, which might enhance the effectiveness of conventional chemotherapy. This approach also offers a more holistic and less invasive option, appealing to those seeking complementary strategies alongside standard treatments.

What evidence suggests that this trial's treatments could be effective for cancer?

This trial will explore the effects of intermittent caloric restriction and a plant-based diet on cancer treatment. Studies have shown that intermittent caloric restriction can slow cancer growth and even kill cancer cells. It also strengthens the immune system and can enhance the effectiveness of chemotherapy. Research indicates that diets mimicking fasting can reduce tumor occurrence by 45% in mice, suggesting potential benefits for humans.

Regarding plant-based diets, research shows they can lower the risk of dying from cancer by about 12% and reduce the overall risk of developing cancer. These diets reduce inflammation and protect cells, aiding in the fight against cancer. Together, these dietary changes may improve the body's response to cancer treatment. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with documented cancer, set to undergo chemotherapy, and have good blood counts and organ function. They must expect to live at least 6 months but can't join if they're too sick (ECOG status >1), recently took certain steroids or vitamin D, are allergic to contrast dye needed for scans, have an infection needing IV antibiotics, or any issue that might affect study participation.

Inclusion Criteria

My liver is functioning within the required limits.

Life expectancy of at least 6 months

My blood counts meet the required levels for treatment.

Exclusion Criteria

I haven't taken strong steroids, high dose vitamin D, had serious infections, or allergies to contrast dye recently.

I need assistance with my daily activities due to my health condition.

I have no health issues that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intermittent caloric restriction and a plant-based diet combined with standard chemotherapy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Intermittent Caloric Restriction
• Plant-based Diet

Trial Overview The study tests whether intermittent caloric restriction combined with a plant-based diet before chemotherapy can boost the treatment's effectiveness against tumors. Participants will alternate days of reduced calorie intake prior to receiving their standard chemotherapy regimen.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Published Research Related to This Trial

Nutritional factors, including dietary composition and calorie intake, significantly influence cancer biology, affecting tumor growth and the effectiveness of anticancer treatments.

Fasting and calorie restriction have been shown to enhance the efficacy of chemotherapy and immunotherapy by improving the body's immune response against cancer cells, highlighting the potential of dietary interventions in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and cancer responses to therapy. Bravo-San Pedro, JM., Pietrocola, F.[2022]

Cancer cells can alter their metabolism to create an environment that suppresses the immune system, which helps tumors grow by changing nutrient levels and releasing substances that attract immune cells that inhibit immune responses.

Dietary interventions like amino acid restriction and fasting mimicking diets may help counteract this immunosuppressive environment by influencing hormone release, reducing inflammation, and improving the structure of blood vessels and the surrounding tissue in tumors, potentially enhancing cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolites and Immune Response in Tumor Microenvironments. Cortellino, S., Longo, VD.[2023]

Calorie restriction (CR) and intermittent fasting have been shown to enhance the effectiveness of cancer treatments like chemotherapy and radiation therapy, while also reducing side effects associated with these therapies.

CR mimetic drugs and alternative diets, such as the ketogenic diet, show promise in improving anticancer therapy outcomes, suggesting that these approaches could be beneficial in future clinical studies for various types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When less may be more: calorie restriction and response to cancer therapy. O'Flanagan, CH., Smith, LA., McDonell, SB., et al.[2020]

Dietary interventions like periodic fasting and fasting-mimicking diets show promise in enhancing the efficacy of cancer therapies and may help prevent cancer, as suggested by preclinical and preliminary clinical studies.

While traditional cancer treatments have remained largely unchanged, emerging dietary strategies could complement these therapies and address the lack of clear nutritional guidelines for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and Caloric Restriction in Cancer Prevention and Treatment. Brandhorst, S., Longo, VD.[2020]

In a study involving patients receiving S-1 adjuvant chemotherapy, the combination of cystine and theanine significantly reduced the incidence of adverse events (AEs), particularly severe diarrhea, compared to a control group.

Patients taking cystine and theanine also had a higher completion rate of chemotherapy and longer duration of treatment, indicating that these amino acids can enhance the tolerability and effectiveness of S-1 chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral administration of the amino acids cystine and theanine attenuates the adverse events of S-1 adjuvant chemotherapy in gastrointestinal cancer patients. Tsuchiya, T., Honda, H., Oikawa, M., et al.[2018]

Nutrient restriction (NR), such as fasting or caloric restriction, shows promise in enhancing the effectiveness of cancer drugs by exploiting the metabolic vulnerabilities of cancer cells, which have a high demand for nutrients to support their growth.

The implementation of NR in clinical settings is complicated by factors like patient biology, cancer type, and treatment adherence, highlighting the need for systematic preclinical studies to identify effective NR and drug combinations and to personalize treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stratifying nutritional restriction in cancer therapy: Next stop, personalized medicine. Krstic, J., Pieber, TR., Prokesch, A.[2021]

Daily caloric restriction (CR) offers more effective protection against tumor growth and lung metastasis in a breast cancer model compared to periodic caloric cycling with a fasting-mimicking diet (FMD).

The enhanced cancer protection from daily CR may be linked to a distinct immune response that is not replicated by the FMD, suggesting that the consistency of dietary restriction plays a crucial role in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily caloric restriction limits tumor growth more effectively than caloric cycling regardless of dietary composition. Pomatto-Watson, LCD., Bodogai, M., Bosompra, O., et al.[2023]

In a study involving 172 women undergoing chemotherapy, intermittent energy restriction (IER) showed a trend towards greater weight and body fat reduction compared to continuous energy restriction (CER), particularly after adjusting for body water.

While the overall incidence of severe chemotherapy toxicities was similar between IER and CER, there was a trend indicating fewer severe toxicities in the IER group during later cycles of treatment, suggesting IER may help reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. Harvie, M., Pegington, M., Howell, SJ., et al.[2022]

Fasting for up to 5 days may protect cancer patients undergoing chemotherapy by significantly reducing glucose and IGF-I levels, potentially enhancing the body's natural defenses without causing chronic weight loss.

In contrast to long-term calorie restriction, which requires weeks to show effects and can lead to weight loss, fasting offers a quicker and more effective way to improve treatment outcomes for cancer patients, suggesting it could be a valuable clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting vs dietary restriction in cellular protection and cancer treatment: from model organisms to patients. Lee, C., Longo, VD.[2011]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405803322002680

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.

2. 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 ...

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

Impact of Fast-Mimicking Diet and Fasting Dietary ... effects of fasting lasted an average of 30 months. Feasibility and impact studies averaged 19 months, while anti-tumor efficacy trials, which require more.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7476366/

Fasting and Caloric Restriction in Cancer Prevention and ... The FMD started at middle age reduces tumor incidence, delays cancer onset, and causes a major reduction in the number of lesions, which may reflect a general ...

5. osher.ucsf.edu osher.ucsf.edu/patient-care/integrative-medicine-resources/cancer-and-nutrition/faq/cancer-and-fasting-calorie-restriction

Cancer and Fasting / Calorie Restriction Fasting and calorie restriction (CR) can slow and even stop the progression of cancer, kill cancer cells, boost the immune system, and significantly improve ...

6. jwatch.org jwatch.org/na58641/2025/04/08/intermittent-fasting-or-daily-caloric-restriction-weight

Intermittent Fasting or Daily Caloric Restriction for Weight ... In a small trial, a 4:3 intermittent-fasting diet resulted in significantly more weight loss than did daily calorie restriction.