What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as gliomas, include surgery, radiation therapy, and chemotherapy. These treatments can have various side effects: surgery may lead to infection, bleeding, or neurological deficits; radiation therapy can cause fatigue, hair loss, and cognitive changes; chemotherapy often results in nausea, vomiting, and increased susceptibility to infections. Metabolic modulation treatments like the ketogenic diet, including the sHFLC + KetoPhyt Diet, are being studied for their potential anti-tumor effects. Known side effects of ketogenic diets can include gastrointestinal issues, nutrient deficiencies, and changes in lipid profiles. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

FDA-approved treatments for brain tumors, particularly glioblastoma multiforme (GBM), typically include a combination of surgery, radiation therapy, and chemotherapy. The standard chemotherapy drug for GBM is temozolomide, often used in conjunction with radiation therapy. Other FDA-approved drugs for brain tumors include bevacizumab, which targets angiogenesis. While metabolic modulation treatments like the sHFLC + KetoPhyt diet are being studied, they are not yet part of the standard FDA-approved treatment regimen for brain tumors.

What other types of research exist?

Promising novel alternatives to the sHFLC + KetoPhyt diet for brain tumor patients include: 1) Bufothionine combined with Temozolomide, which has shown synergistic effects in suppressing glioblastoma multiforme cell growth. 2) Gamma-tocotrienol and hydroxy-chavicol, which synergistically inhibit growth and induce apoptosis in glioma cells. 3) Everolimus, which has demonstrated long-term efficacy and safety in treating subependymal giant cell astrocytoma associated with tuberous sclerosis complex.

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Dietary Supplement

Ketogenic Diet for Brain Cancer

N/A

Waitlist Available

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with high-grade gliomas (World Health Organization [WHO] Grade III/IV) with newly diagnosed or recurrent disease

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

Must not have

Concurrent investigational agents or other glioma-directed therapy (chemotherapy, radiation) while on study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at cycle 1 day 1 and at cycle 6 day 1 (each cycle is 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special diet called sHFLC + KetoPhyt for patients with aggressive brain tumors. The diet aims to lower blood sugar and increase ketones, which might help fight cancer. Researchers hope this diet will be easier for patients to follow and still be effective. The ketogenic diet has been studied for its potential to fight tumors by causing oxidative stress and slowing tumor growth.

Who is the study for?

This trial is for people with high-grade gliomas (serious brain tumors). Participants should be in a stable condition, able to perform daily activities with some effort or better, and have normal organ function. They must not be pregnant or breastfeeding and should not be receiving other experimental treatments.

What is being tested?

The KetoGlioma Study is testing an experimental diet called supplemented High-Fat Low-Carbohydrate (sHFLC) + KetoPhyt to see if it's possible for patients to stick to this diet and how it might impact cancer cells in the blood.

What are the potential side effects?

Potential side effects are not detailed here but could include typical reactions associated with dietary changes such as digestive discomfort, changes in energy levels, or nutritional deficiencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You cannot be receiving any other experimental or approved treatments for your brain tumor while participating in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at cycle 1 day 1 and at cycle 6 day 1 (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at cycle 1 day 1 and at cycle 6 day 1 (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at cycle 1 day 1 and at cycle 6 day 1 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants not able to adhere the sHFLC + KetoPhyt Diet

Secondary study objectives

Change from baseline between the patient's glucose and ketone levels at 24 weeks as assessed by the Glucose/Ketone Index (GKI)

Change from baseline between the patient's gut microbiome at 24 weeks as assessed by 16s ribosomal sequences.

Change from baseline in pro-inflammatory markers and exosome biomarkers at 24 weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhytExperimental Treatment1 Intervention

Subjects will adhere to the sHFLC + KetoPhyt diet for six 4-week cycles.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors, such as gliomas, include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible, radiation therapy uses high-energy waves to kill cancer cells, and chemotherapy employs drugs to target and destroy rapidly dividing cells. Metabolic modulation, such as the sHFLC + KetoPhyt Diet, focuses on altering the tumor's energy supply by reducing glucose and enhancing ketone bodies, which tumors are less efficient at using for energy. This approach is significant for brain tumor patients as it targets the unique metabolic vulnerabilities of cancer cells, potentially improving treatment outcomes and survival rates.

Ketogenic Diet for Malignant Gliomas: a Review.Investigating the Ketogenic Diet As Treatment for Primary Aggressive Brain Cancer: Challenges and Lessons Learned.The role of emerging therapy in the management of patients with diffuse low grade glioma.