Ketogenic Diet for Skin and Kidney Cancers

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must be taking: Immune checkpoint inhibitors

Disqualifiers: Diabetes, Underweight, Active malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a ketogenic diet (low in carbs, high in fats) can enhance the effectiveness of immunotherapy for certain advanced skin and kidney cancers. Researchers aim to determine if shifting the body's energy source from sugar to fat can improve the immune system's ability to fight cancer. Participants will either follow a ketogenic diet with dietician support or continue their usual diet. The trial seeks participants with metastatic melanoma or kidney cancer who are already receiving specific immunotherapy treatments. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance cancer treatment options.

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, it does require that you follow a ketogenic diet and be on specific immunotherapy treatments for melanoma or kidney cancer.

What prior data suggests that this ketogenic dietary intervention is safe for patients with metastatic melanoma and kidney cancer?

Research has shown that ketogenic diets (KDs) are generally safe and well-tolerated by cancer patients. Reports and smaller studies support this, noting that most patients manage the diet without major issues. Although larger studies would provide more detailed information, current evidence suggests that side effects are minor and manageable. These may include initial tiredness or digestive changes, which often improve over time. Consulting a healthcare provider before making any dietary changes is important, but KDs have a good safety record in cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a ketogenic diet for treating skin and kidney cancers because it offers a unique approach compared to standard treatments like chemotherapy, radiation, or targeted therapies. Unlike these conventional methods, the ketogenic diet alters the body's metabolism by reducing carbohydrate intake and increasing fat consumption, which may help starve cancer cells that rely on glucose for energy. Additionally, this dietary intervention is supported by personalized coaching and continuous ketone monitoring, providing patients with hands-on support and potentially improving adherence and outcomes. This novel approach could offer a less invasive and more patient-centered option for managing these cancers.

What evidence suggests that a ketogenic diet could be effective for metastatic melanoma and kidney cancer?

This trial will compare a ketogenic dietary intervention with usual care for patients with skin and kidney cancers. Research has shown that a ketogenic diet, which involves eating fewer carbohydrates and more fats, might slow tumor growth. In animal studies, this diet reduced tumor growth rates. It may also enhance the body's response to cancer treatments like immunotherapy, which aids the immune system in fighting cancer. Some studies have found that cancer patients on a ketogenic diet experience better treatment outcomes compared to those on regular diets. While more research is needed in humans, these findings suggest possible benefits for people with advanced melanoma and kidney cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Marium Husain, MD, MPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with metastatic melanoma or kidney cancer. Participants should be eligible for immunotherapy and willing to follow a ketogenic diet, which means eating fewer carbs and more fats.

Inclusion Criteria

I have metastatic melanoma and am on my first treatment.

I have metastatic renal cell carcinoma and am on my first treatment.

Willing to provide stool specimen for research studies as outlined

Exclusion Criteria

I am under 18 years old.

Pregnant women

I am underweight with a BMI below 18.5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a ketogenic dietary intervention with personalized coaching and continuous ketone monitoring over 24 weeks

24 weeks

Regular visits and continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and adherence

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Dietary Intervention

Trial Overview The study tests if a ketogenic diet can boost the effectiveness of immune checkpoint inhibitors (a type of immunotherapy) in treating metastatic melanoma and kidney cancer.

How Is the Trial Designed?

Group I: Arm I (Ketogenic diet) Experimental Treatment 7 Interventions

Patients undergo a ketogenic dietary intervention with personalized coaching from a dietician about the KD, which includes extensive educational and ongoing support on the KD and continuous ketone monitoring by talking to a dietician directly, with the ability to text a dietician at any time and expect a response within 12 hours over 24weeks. Patients also undergo daily blood glucose and ketone monitoring, undergo CT, undergo blood sample collection and may undergo stool sample collection on the study.

Group II: Arm II (usual caare) Active Control 1 Intervention

Patients follow a standard of care diet on the study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

In a study of 60 breast cancer patients undergoing chemotherapy, those on a ketogenic diet (KD) showed significant improvements in fasting blood sugar levels and body composition, including reduced BMI and body fat percentage, compared to a standard diet.

The KD group also experienced a higher overall survival rate compared to the control group, with no severe adverse effects noted, indicating that KDs can be a safe and effective adjunct to chemotherapy for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Safety, and Beneficial Effects of MCT-Based Ketogenic Diet for Breast Cancer Treatment: A Randomized Controlled Trial Study. Khodabakhshi, A., Akbari, ME., Mirzaei, HR., et al.[2021]

A ketogenic diet, while effective as an anti-seizure therapy, was found to promote excessive growth of renal tumors in Eker rats over long-term use, indicating potential risks associated with its prolonged application.

The diet activates both pro-cancerous pathways (ERK1/2 and mTOR) and some antitumor mechanisms (Nrf2 and p53), but the tumor-promoting effects ultimately outweighed the protective responses, suggesting caution in its use for patients with tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term High Fat Ketogenic Diet Promotes Renal Tumor Growth in a Rat Model of Tuberous Sclerosis. Liśkiewicz, AD., Kasprowska, D., Wojakowska, A., et al.[2021]

A modified Atkins diet, consisting of low carbohydrates, was found to be safe and feasible for 17 advanced cancer patients, with quality of life preserved and significant weight loss observed in all participants.

Patients who lost at least 10% of their body weight showed better clinical responses, with some experiencing improved survival rates, suggesting that dietary management may play a role in cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Atkins diet in advanced malignancies - final results of a safety and feasibility trial within the Veterans Affairs Pittsburgh Healthcare System. Tan-Shalaby, JL., Carrick, J., Edinger, K., et al.[2022]

In a study of 200 older patients (median age 70) on a ketogenic diet, 67% reported beneficial outcomes, including significant weight loss for 79% of those seeking it, improved glucose control for 54% of those with diabetes, and positive effects on cancer outcomes for 63% of patients pursuing that goal.

While the ketogenic diet showed promise for various health issues in older adults, 15% of participants experienced adverse events, including dyslipidemia and constipation, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. Almodallal, Y., Cook, K., Lammert, LM., et al.[2023]

A ketogenic diet was found to slow down tumor growth in mice, suggesting a potential benefit in controlling cancer progression.

However, despite the slowed tumor growth, the ketogenic diet was associated with worsened overall survival in the mice, indicating that it may not be a safe or effective long-term treatment strategy for cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Ketogenic Diet Induces Tumor Ferroptosis but Accelerates Cachexia. [2023]

The ketogenic diet (KD) showed potential in reducing tumor growth in renal cell carcinoma (RCC) models, but it also led to significant weight loss and reduced survival in mice, indicating a need for caution in its application.

While KDs did not cause liver inflammation in healthy mice, they may exacerbate hepatic dysfunction in RCC patients with Stauffer's syndrome due to increased inflammatory cytokine levels, suggesting that KDs might not be safe for all RCC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet is not feasible as a therapy in a CD-1 nu/nu mouse model of renal cell carcinoma with features of Stauffer's syndrome. Vidali, S., Aminzadeh-Gohari, S., Feichtinger, RG., et al.[2018]

Ketogenic diets significantly reduced tumor growth and metastasis in various melanoma models, including those with different genetic backgrounds and immune statuses, indicating their broad efficacy as a complementary cancer therapy.

The diets altered multiple metabolic pathways, notably reducing levels of alpha-amino adipic acid, a cancer biomarker, and increasing sphingomyelin levels, suggesting a complex mechanism of action that creates an unfavorable environment for melanoma cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diets slow melanoma growth in vivo regardless of tumor genetics and metabolic plasticity. Weber, DD., Aminzadeh-Gohari, S., Thapa, M., et al.[2022]

The ketogenic diet did not significantly improve glycaemic control or body weight in patients with type 2 diabetes compared to control diets, based on a review of 11 randomized controlled trials.

However, the ketogenic diet was associated with increased levels of HDL (good cholesterol) and reduced triglycerides, suggesting potential benefits for lipid profiles in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the ketogenic diet for the management of type 2 diabetes mellitus: A systematic review and meta-analysis of recent studies. Choy, KYC., Louie, JCY.[2023]

A review of 11 studies involving 102 cancer patients showed that while ketogenic diets are being explored as a complementary therapy, the evidence regarding their impact on nutritional status, tumor effects, and quality of life is inconclusive.

Adherence to the ketogenic diet was low, with only 49% of participants sticking to it, indicating that more controlled trials are needed to better understand the effectiveness and safety of this dietary approach in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the use of ketogenic diets in adult patients with cancer. Sremanakova, J., Sowerbutts, AM., Burden, S.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06391099

NCT06391099 | Ketogenic Dietary Intervention to Improve ... This phase I trial studies how well a ketogenic dietary intervention works to improve response to immunotherapy in patients with melanoma and kidney cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6375425/

Ketogenic Diets and Cancer: Emerging Evidence - PMC Combining a ketogenic diet with standard chemotherapeutic and radiotherapeutic options may help improve tumor response, although more research is needed.

3. withpower.com withpower.com/trial/phase-skin-neoplasms-4-2024-7bb49

Ketogenic Diet for Skin and Kidney Cancers A ketogenic diet was found to slow down tumor growth in mice, suggesting a potential benefit in controlling cancer progression. However, despite the slowed ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06896552

Single-Center Trial on Ketogenic Diet and Immunotherapy ... This clinical trial aims to evaluate whether a ketogenic diet (KD), when combined with immunotherapy, can improve immune function and treatment outcomes in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12313497/

Impact of ketogenic diets on cancer patient outcomes The ketogenic diet was found to improve cancer patients' outcomes more effectively than non-ketogenic diets. Notably, C-reactive protein levels ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-01894

Ketogenic Dietary Intervention to Improve Response ... This phase I trial studies how well a ketogenic dietary intervention works to improve response to immunotherapy in patients with melanoma and kidney cancer ...

7. ctv.veeva.com ctv.veeva.com/study/single-center-trial-on-ketogenic-diet-and-immunotherapy-in-advanced-cancer-this-study-evaluates-the

Single-Center Trial on Ketogenic Diet and Immunotherapy in ... This clinical trial aims to evaluate whether a ketogenic diet (KD), when combined with immunotherapy, can improve immune function and treatment ...