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

Trial Summary

What is the purpose of this trial?

Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.

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.

What data supports the effectiveness of the treatment Caloric Restriction and Plant-Based Diet for Cancer?

Research suggests that intermittent fasting and caloric restriction can protect normal cells and enhance the effectiveness of chemotherapy by reducing glucose and growth factor levels, which cancer cells rely on. Additionally, plant-based diets that mimic fasting cycles have shown potential in reducing tumor growth without the need for chronic calorie restriction. ^{1 2 3 4 5}

Is caloric restriction and plant-based diet safe for humans during cancer treatment?

Research suggests that intermittent fasting and caloric restriction can reduce some side effects of chemotherapy and may enhance its effectiveness. These dietary approaches have shown promising results in preclinical studies for improving cancer treatment and reducing side effects, but more clinical studies are needed to confirm their safety and effectiveness in humans. ^{1 3 4 6 7}

How does the caloric restriction and plant-based diet treatment differ from other cancer treatments?

This treatment is unique because it combines caloric restriction with a plant-based diet to enhance the effectiveness of chemotherapy by potentially boosting the body's immune response against cancer. Unlike traditional treatments that focus solely on drugs, this approach uses dietary changes to improve cancer therapy outcomes. ^{1 3 5 8 9}

Eligibility Criteria

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

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

Treatment Details

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Daily caloric restriction limits tumor growth more effectively than caloric cycling regardless of dietary composition. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Fasting and Caloric Restriction in Cancer Prevention and Treatment. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Metabolites and Immune Response in Tumor Microenvironments. [2023]

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

When less may be more: calorie restriction and response to cancer therapy. [2020]

7. Japan 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. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Stratifying nutritional restriction in cancer therapy: Next stop, personalized medicine. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Fasting and cancer responses to therapy. [2022]