The KetoGlioma (Ketogenic Glioma) Study

NCT05373381 | Withdrawn

• 2 other identifiers: KetoGliomaSTUDY00001948
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 affect cancer cells in the bloodstream. This diet is experimental and is not routinely prescribed for patients with high-grade gliomas. The results of this study may be used to support larger studies investigating possible anti-tumor affects of the sHFLC + KetoPhyt diet.

Conditions

Glioma

Keywords

Glioma; KetoPhyt; High-grade gliomas

Outcome Measures

Primary Outcomes (1)

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

  Patients' ability to adhere to the sHFLC + KetoPhyt Diet as defined by the presence of the following: 1. \>75% compliance with taking supplement 2x/day throughout the study period 2. \>75% of days with carbohydrate intake \<33%

  From Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days)

Secondary Outcomes (3)

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

  Measured daily from Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days)

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

  At Cycle 1 Day 1 and at Cycle 6 Day 1 (Each cycle is 28 days)

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

  Measured daily from Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days)

Study Arms (1)

Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt

EXPERIMENTAL

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

Dietary Supplement: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt

Interventions

Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt DIETARY_SUPPLEMENT

Following a screening period, subjects will adhere to the sHFLC + KetoPhyt diet for six 4-week cycles. Patients will receive dietary advice from a Registered Dietitian (RD) to allow for the design of personalized meal plans maintaining carbohydrates up to 33% of total caloric intake, and be asked to maintain a daily dietary log. To assist patients in understanding, monitoring and controlling their dietary choices to maintain a low carbohydrate diet, they will be trained and receive assistance on the use of an online tool for tracking nutrition \[Healthtrac\].

Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 13, 2022
• Study Start: May 18, 2022
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

US (1)