Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|18 Years and Over
- - 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.
- - Concurrent investigational agents or other glioma-directed therapy (chemotherapy, radiation) while on study.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Tufts Medical Center
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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].
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Tufts Medical Center
Boston, Massachusetts, 02111