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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
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
Study Summary
This trial is testing whether a high-fat, low-carbohydrate diet supplemented with ketones can help treat high-grade gliomas, and whether the diet has any effect on cancer cells in the bloodstream.
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.Check my eligibility
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.See study design
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 belowTimeline
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants not able to adhere the sHFLC + KetoPhyt Diet
Secondary outcome measures
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
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.
Find a Location
Who is running the clinical trial?
Tufts Medical CenterLead Sponsor
252 Previous Clinical Trials
252,998 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been taking the same dose of steroids for at least 7 days.You are currently pregnant or breastfeeding.You cannot be receiving any other experimental or approved treatments for your brain tumor while participating in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants being sought for this study?
"According to the information on clinicaltrials.gov, this medical study is not currently open for recruitment. Initially launched back in November 1st 2022 and last edited a few weeks ago, October 10th 2022; nevertheless, there are still 356 other trials actively searching for patients right now."
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