Keto Diet vs Standard Cancer Diet for Glioblastoma

Recruiting at 5 trial locations

Overseen By Clinical Trial Recruitment Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Recurrent glioblastoma, Genetic disorders, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

170 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, it does mention that off-label therapy use is permitted, which might suggest some flexibility. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the ketogenic diet treatment for glioblastoma?

Research suggests that ketogenic diets may help reduce tumor growth and improve survival in glioma patients by lowering blood sugar levels. Some studies have shown beneficial effects on survival and progression-free survival, but more high-quality research is needed to confirm these findings. ^{1 2 3 4 5}

Is the ketogenic diet safe for humans, particularly in cancer treatment?

The ketogenic diet (KD) has been generally well-tolerated in clinical studies, with only minor side effects reported, such as constipation. Adverse events attributed to the diet were rare and mostly minor, except for one severe event. Overall, KD appears safe for use in humans, including those undergoing cancer treatment, but more high-quality studies are needed to confirm these findings. ^{1 4 5 6 7}

How is the ketogenic diet treatment unique for glioblastoma?

The ketogenic diet is unique for glioblastoma because it aims to starve cancer cells by reducing blood glucose levels, which these cells rely on for growth, while providing energy through ketones that normal brain cells can use more efficiently. ^{1 3 4 7 8}

What is the purpose of this trial?

This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence. This two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.

Research Team

Jethro Hu, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed glioblastoma who haven't started chemotherapy or radiation. They must be able to perform daily activities well (KPS ≥ 70), read and understand English or Spanish, and commit to the study's requirements. Excluded are those with recurrent glioblastoma, certain genetic disorders, high steroid needs, pregnancy/nursing status, other experimental therapies, comorbidities that limit participation as per investigator's opinion, electronic medical implants unsafe for MRIs (with some exceptions), BMI < 21kg/m2 unless deemed safe by the investigator.

Inclusion Criteria

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

I was diagnosed with glioblastoma less than 2 months ago.

I haven't started treatment for glioblastoma yet.

Exclusion Criteria

I have a genetic disorder that affects how my body processes fats.

I cannot reduce my steroid dose below 8mg of dexamethasone or its equivalent per day.

My glioblastoma has come back after treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either a Keto Diet or Standard Anti-Cancer Diet for 18 weeks, alongside standard of care treatment for glioblastoma

18 weeks

Regular visits for diet monitoring and standard care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life, cognitive performance, and physical activity

18 weeks

Long-term Follow-up

Participants' overall survival is tracked for up to 18 months from baseline

18 months

Treatment Details

Interventions

• Keto Diet
• Usual Diet

Trial Overview The study compares two diets in patients with glioblastoma: a Keto Diet versus a Standard Anti-Cancer Diet. Each participant will also receive standard cancer treatments alongside their assigned diet. The Keto Diet group will have an 18-week intervention monitored by research dietitians through daily ketone and glucose level checks.

Participant Groups

Group I: Keto-Diet Experimental Treatment 1 Intervention

Intensive 18-week Keto Diet intervention.

Group II: Standard Anti-Cancer Diet Placebo Group 1 Intervention

Standard Anti-Cancer Diet with Dietitian support

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A review of 13 studies involving 187 glioma patients indicates that ketogenic diets (KD) may inhibit glioma growth and help manage symptoms, but there is significant variability in how these diets are implemented.

The lack of standardization in ketogenic diet protocols for glioma patients complicates comparisons of their effectiveness, highlighting the need for a consensus on dietary definitions and methods to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological Approaches to Ketogenic Dietary Treatments in Glioma Patients from a Nutritional Point of View. Guo, A., Asztely, F., Smits, A., et al.[2022]

A systematic review of six studies involving 39 patients found no randomized clinical trials on the effectiveness of ketogenic diets (KDs) for treating gliomas, indicating a lack of high-quality evidence.

While all studies reported on survival outcomes, the actual effectiveness and dietary acceptability of KDs remain unclear, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of ketogenic diets in the therapeutic management of adult and paediatric gliomas: a systematic review. Martin-McGill, KJ., Srikandarajah, N., Marson, AG., et al.[2019]

Preclinical studies indicate that ketogenic or caloric restricted diets (KCRDs) can reduce tumor growth in malignant gliomas, particularly when blood glucose levels are decreased, although improved survival was only observed in a minority of cases.

Preliminary clinical data suggest that KCRDs are safe and feasible for glioma patients, but there is not enough evidence yet to confirm their effectiveness in improving survival or quality of life, highlighting the need for further prospective studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of malignant gliomas with ketogenic or caloric restricted diets: A systematic review of preclinical and early clinical studies. Noorlag, L., De Vos, FY., Kok, A., et al.[2022]

A systematic review of 13 clinical studies involving ketogenic diets (KDs) alongside cancer treatments showed that KDs can have beneficial effects on overall survival and progression-free survival in some patients, with four studies reporting positive outcomes.

Adverse events related to the ketogenic diet were mostly minor, indicating that KDs are generally safe to use in conjunction with other oncological therapies, although more rigorous studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diets in medical oncology: a systematic review with focus on clinical outcomes. Klement, RJ., Brehm, N., Sweeney, RA.[2020]

A modified ketogenic diet (MKD) was well tolerated by glioma patients, with only minor side effects like constipation reported, and it was achievable within a standard healthcare service.

Out of 172 surveyed patients, 69% supported offering MKD as a treatment option, and 73% expressed willingness to try it for 3 months, indicating strong interest in future clinical trials to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Modified Ketogenic Diet in Adults with Glioblastoma: An Evaluation of Feasibility and Deliverability within the National Health Service. Martin-McGill, KJ., Marson, AG., Tudur Smith, C., et al.[2022]

This pilot study aims to evaluate the feasibility and tolerability of two different ketogenic diets in 12 patients with newly diagnosed glioblastoma, focusing on their impact on patient health and quality of life over 12 weeks and 12 months.

The results will help determine which ketogenic diet is more deliverable and adherable for patients, providing essential insights for future larger trials assessing the effectiveness of ketogenic diets as an additional treatment for glioblastoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diets as an adjuvant therapy in glioblastoma (the KEATING trial): study protocol for a randomised pilot study. Martin-McGill, KJ., Marson, AG., Tudur Smith, C., et al.[2022]

The ketogenic diet (KD) was found to be safe for glioma patients, with no major side effects reported, and it can be induced using regular foods.

While the two patients in the pilot study experienced tumor progression on the energy-restricted ketogenic diet, some literature reports indicated prolonged remissions in other patients, suggesting that KD may help control glioma progression in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of glioma patients with ketogenic diets: report of two cases treated with an IRB-approved energy-restricted ketogenic diet protocol and review of the literature. Schwartz, K., Chang, HT., Nikolai, M., et al.[2023]

The ketogenic diet (KD) has been shown to be an effective therapy for patients with malignant gliomas, with a mean overall survival of 15.9 months reported across nine studies.

While the KD may improve survival rates, its impact on quality of life remains inconclusive, with only 44.4% of studies reporting improvements in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Ketogenic Diet in the Treatment of Gliomas: A Systematic Review. Sargaço, B., Oliveira, PA., Antunes, ML., et al.[2022]

References

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

Methodological Approaches to Ketogenic Dietary Treatments in Glioma Patients from a Nutritional Point of View. [2022]

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

The role of ketogenic diets in the therapeutic management of adult and paediatric gliomas: a systematic review. [2019]

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

Treatment of malignant gliomas with ketogenic or caloric restricted diets: A systematic review of preclinical and early clinical studies. [2022]

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

Ketogenic diets in medical oncology: a systematic review with focus on clinical outcomes. [2020]

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

The Modified Ketogenic Diet in Adults with Glioblastoma: An Evaluation of Feasibility and Deliverability within the National Health Service. [2022]

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

Ketogenic diets as an adjuvant therapy in glioblastoma (the KEATING trial): study protocol for a randomised pilot study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Treatment of glioma patients with ketogenic diets: report of two cases treated with an IRB-approved energy-restricted ketogenic diet protocol and review of the literature. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of the Ketogenic Diet in the Treatment of Gliomas: A Systematic Review. [2022]