Status:
WITHDRAWN
The KetoGlioma (Ketogenic Glioma) Study
Lead Sponsor:
Tufts Medical Center
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This research is being conducted to see if patients diagnosed with high grade gliomas can adhere to the supplemented High-Fat Low-Carbohydrate (sHFLC) + KetoPhyt diet, and to see how this diet might a...
Detailed Description
This study is designed to analyze the feasibility of using the sHFLC + KetoPhyt as an anti-cancer agent against glioblastoma multiforme (GBM). While the classic ketogenic diet typically uses a 4:1 rat...
Eligibility Criteria
Inclusion
- Patients with high-grade gliomas (World Health Organization \[WHO\] Grade III/IV) with newly diagnosed or recurrent disease
- Ability to understand and willingness to sign an informed consent form prior to any study procedures
- For patients treated with external beam radiation (XRT), interstitial brachytherapy or radiosurgery, an interval of \> 4 weeks must have elapsed from completion of XRT to pre-registration.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia.
- Steroid dosing stable for at least 7 days
- Adequate organ function as defined by the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet Count ≥ 100,000/mm3
- Creatinine ≤ 1.5 mg/dl x upper limit of normal (ULN)
- Creatinine Clearance ≥ 45 mL/min
- Total Bilirubin ≤ 1.5 x ULN (except in cases of Gilbert's disease)
- AST (aspartate aminotransferase)/ ALT (alanine transaminase) ≤ 2.5 x ULN
Exclusion
- Concurrent investigational agents or other glioma-directed therapy (chemotherapy, radiation) while on study.
- Pregnant or breastfeeding
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05373381
Start Date
May 18 2022
End Date
May 18 2022
Last Update
February 2 2024
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111