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Ketogenic Diet + Radiation & Chemotherapy for Glioblastoma

Q: Has the FDA approved any therapeutic uses of a Ketogenic Diet?

<p>Ketogenic <a href="https://www.withpower.com/clinical-trials/diet">Diet</a>'s safety was judged to be a 1 on our scale, since this is an early-stage trial and there are only limited data available regarding its efficacy.</p>

Phase 1

Waitlist Available

Led By Jethro Hu, MD

Research Sponsored by Jethro Hu

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four months

Awards & highlights

Study Summary

This trial is testing whether a ketogenic diet can help treat cancer alongside standard radiation and chemotherapy.

Who is the study for?

Adults over 18 with newly diagnosed glioblastoma can join this trial if they're being treated at Cedars-Sinai Medical Center or elsewhere for chemotherapy/radiation. They must be able to follow a ketogenic diet, have a BMI of ≥22, and be on low doses of steroids. Excluded are those with certain medical conditions, high steroid doses, vegan/vegetarian diets, allergies to specific materials used in the study tools, and incompatible implants.Check my eligibility

What is being tested?

The trial tests how well patients with glioblastoma respond to a personalized 16-week ketogenic diet while undergoing standard cancer treatments like radiation and Temozolomide. Dietitians will tailor meal plans aiming for metabolic ketosis. Patient safety, nutrition levels, life quality, and tumor response are monitored throughout.See study design

What are the potential side effects?

Potential side effects from the ketogenic diet may include fatigue, constipation or diarrhea due to dietary changes. Standard-of-care radiation might cause skin irritation or hair loss at the treatment site; Temozolomide could lead to nausea/vomiting, headaches or blood-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four months

This trial's timeline: 3 weeks for screening, Varies for treatment, and four months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of the intervention

Secondary outcome measures

Cognitive function (Controlled Word Association Test)

Cognitive function (Hopkins Verbal Learning Test-Revised)

Cognitive function (Montreal Cognitive Assessment)

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketogenic diet+radiation+temozolomideExperimental Treatment3 Interventions

Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jethro HuLead Sponsor

Jethro Hu, MDPrincipal InvestigatorCedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

2 Previous Clinical Trials

209 Total Patients Enrolled

2 Trials studying Glioblastoma

209 Patients Enrolled for Glioblastoma

Media Library

Glioblastoma Clinical Trial 2023: Standard-of-care radiation Highlights & Side Effects. Trial Name: NCT03451799 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved any therapeutic uses of a Ketogenic Diet?

"Ketogenic Diet's safety was judged to be a 1 on our scale, since this is an early-stage trial and there are only limited data available regarding its efficacy."

Answered by AI

To what ailments is the Ketogenic Diet regularly applied?

"The Ketogenic Diet has been employed to treat nitrosourea treatment, end-of-life directives, refractory malignancies such as mycosis fungoides and neuroblastoma."

Answered by AI

Are there any unfilled positions for participants in this research endeavor?

"According to clinicaltrials.gov, this medical trial is not actively accepting patients at the present time. The original post date was April 13th 2018 and it has since been updated on July 12th 2022. Nevertheless, 648 other trials are still searching for participants as of now."

Answered by AI

Have any previous experiments tested the efficacy of a Ketogenic Diet?

"Currently, there are 206 clinical trials that examine the effects of a Ketogenic Diet. Of these studies, 23 have entered Phase 3 and many are based in Seoul-Songpa with 4751 sites across the globe offering this treatment to participants."

Answered by AI

How many participants are eligible for inclusion in this trial?

"This clinical trial has now closed its recruitment period, having first been published on April 13th 2018 and last edited on July 12th 2022. If you're interested in other trials for glioblastoma there are currently 442 studies enrolling patients, as well as 206 studies related to the Ketogenic Diet actively looking for participants."

Answered by AI

Is this a pioneering attempt at the research?

"Initially trialled in 2002 and sponsored by Schering-Plough, the Ketogenic Diet has seen a surge of research since then. Subsequent trials led to Phase 2 drug approval, with 206 active studies spanning over 935 cities and 36 countries today."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma

Jethro Hu 2018. "Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03451799.

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