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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a Keto Diet can improve survival for individuals recently diagnosed with glioblastoma, a type of brain cancer. The study includes two groups: one will follow a Keto Diet, while the other will adhere to a standard anti-cancer diet. Both groups will receive regular cancer treatment. Researchers aim to determine if the Keto Diet affects patient outcomes. Individuals diagnosed with glioblastoma within the last two months who have not yet started cancer treatment may be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

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

Research has shown that the ketogenic (keto) diet is generally safe for people with glioblastoma, a type of brain tumor. In one study, patients on a keto diet lived longer. Another study found the diet safe and feasible for these patients, suggesting it might help when combined with standard treatments.

The keto diet is high in fats and low in carbohydrates, altering how the body obtains energy. While most people tolerate the diet well, side effects like tiredness, constipation, or changes in blood sugar can occur. With guidance from dietitians, most people manage these issues effectively. Overall, research supports the safety of the keto diet for people with glioblastoma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glioblastoma?

Unlike the standard treatments for glioblastoma, which typically include surgery, radiation, and chemotherapy, the keto diet offers a unique approach by heavily restricting carbohydrates and increasing fats. This diet may starve cancer cells of the glucose they rely on, potentially slowing tumor growth. Researchers are excited about the keto diet because it could provide a non-invasive, dietary-based treatment option that complements existing therapies and may improve patients' quality of life.

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

Research has shown that a ketogenic (keto) diet might help people with glioblastoma, a type of brain tumor, live longer. One study found that patients on a keto diet had better survival rates. Another study suggested the diet could improve results for patients receiving standard cancer treatments. In this trial, participants will follow either an intensive 18-week Keto Diet intervention or a Standard Anti-Cancer Diet with dietitian support. Previous findings suggest that the keto diet could be a promising part of treatment for glioblastoma. ^{1 2 4 6 7}

Who Is on the Research Team?

Jethro Hu, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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

I was diagnosed with glioblastoma less than 2 months ago.

Ability to read, write and understand either English OR Spanish

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433106/

The Role of the Ketogenic Diet in Managing Glioblastoma in ... According to the findings of our study, patients with brain tumors who stick to a ketogenic diet are more likely to experience improved survival rates.

2. cancerresearchuk.org cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-types-of-ketogenic-diet-in-people-with-glioblastoma-keating

A study comparing types of ketogenic diet in people with ... The study compared 2 types of ketogenic diets in people with a glioblastoma (GBM). Glioblastomas are a type of brain tumour. A ketogenic diet is high in fat ...

3. nature.com nature.com/articles/s41598-025-06675-6

A phase 1 safety and feasibility trial of a ketogenic diet plus ... This phase 1 trial demonstrates that KD is safe and feasible for GBM patients receiving SOC, may improve outcomes, and provides a foundation for an NCI-funded ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0007455125003327

Prospects of the therapeutic approaches of ketogenic diet ... Nearly almost of the studies found that there was a potential role of KD in the prognosis of cancer treatment. The current review suggests that cancer patients ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1489812/full

Successful application of dietary ketogenic metabolic ... Consequently, the survival rate among these patients is 4 out of 6, or 66.7%. Of the 12 patients who did not adhere to the diet, only one reached 36 months of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03075514

Ketogenic Diets as an Adjuvant Therapy in Glioblastoma This trial will see patients randomly assigned to one of two types of KDs; the modified ketogenic diet (MKD) and the medium chain triglyceride ketogenic diet ( ...

7. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03775-4

Clinical research framework proposal for ketogenic ... We present a consensus treatment protocol based on the metabolic requirements of GBM cells for the two major fermentable fuels: glucose and glutamine.