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The KetoGlioma (Ketogenic Glioma) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05373381
Recruitment Status : Not yet recruiting
First Posted : May 13, 2022
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Glioma Dietary Supplement: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt Not Applicable

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 ratio of fat to proteins/carbohydrates, the sHFLC + KetoPhyt diet has a maximum 2:1 ratio. This allows increased flexibility in the diet and improved nutritional sufficiency. Preclinical and controlled patient data supports that the sHFLC + KetoPhyt diet is able to decrease blood glucose levels while increasing circulating ketones, two key effects of the ketogenic diet. As caloric restriction is not used in this approach, the investigators hypothesize that patients will be able to have an increased dietary compliance compared to those patients on the very restrictive ketogenic diet, but still achieve a ketotic state.

There is general consensus in the field that the use of the phyto anti-inflammatory diet and exogenous ketone supplementation can all lead to ketosis in a matter of days, and not become what is referred to as ketone adaptative for many weeks to months. Ketosis, with blood levels of the ketone body beta-hydroxy- butarate >0.5 mM, undergoes an adaptive process where different tissues at different times alter the biochemistry of their cellular fuel sources following the switching from a glucose- to fat- and lipid-metabolism. This affects the ability to precisely measure different states of ketosis in the study population over time as the adaptive processes are temporally unique, however previous studies have described the "…adaptation periods necessary… for particular tissue ketone oxidation following sustained nutritional ketosis…" , and these investigators even related this to inflammation-associated cytokine expressions as the investigators propose to measure in this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Modified Ketogenic, Anti-Inflammatory Diet for Patients With High-Grade Gliomas
Estimated Study Start Date : February 1, 2023
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
Subjects will adhere to the sHFLC + KetoPhyt diet for six 4-week cycles.
Dietary Supplement: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
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].




Primary Outcome Measures :
  1. Number of participants not able to adhere the sHFLC + KetoPhyt Diet [ Time Frame: From Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days) ]

    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%


Secondary Outcome Measures :
  1. Change from baseline between the patient's glucose and ketone levels at 24 weeks as assessed by the Glucose/Ketone Index (GKI) [ Time Frame: Measured daily from Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days) ]
    Blood glucose and ketone levels measured at the same time once per day from baseline to 24 weeks via a glucose/ketone monitor and test strips. The Glucose/Ketone Index will be used to monitor patient's glucose and ketone levels.

  2. Change from baseline in pro-inflammatory markers and exosome biomarkers at 24 weeks [ Time Frame: At Cycle 1 Day 1 and at Cycle 6 Day 1 (Each cycle is 28 days) ]
    Comparison of the numbers of EGFrVIII+ exosomes and exosomal microRNAs in each participant's blood measured at baseline (Cycle 1 Day 1) and 24 weeks (Cycle 6).

  3. Change from baseline between the patient's gut microbiome at 24 weeks as assessed by 16s ribosomal sequences. [ Time Frame: Measured daily from Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days) ]
    DNA purified from stool samples (16s ribosomal sequences) will be compared at baseline and 24 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05373381


Contacts
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Contact: Latoya Lashley, MPH 617-636-3264 ncccr@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Contact: Latoya Lashley, MPH    617-636-3264    ncccr@tuftsmedicalcenter.org   
Principal Investigator: Suriya Jeyapalan, MD         
Sponsors and Collaborators
Tufts Medical Center
Publications:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT05373381    
Other Study ID Numbers: KetoGlioma
STUDY00001948 ( Other Identifier: Tufts Medical Center )
First Posted: May 13, 2022    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tufts Medical Center:
Glioma
KetoPhyt
High-grade gliomas
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue