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Keto Diet vs Standard Cancer Diet for Glioblastoma

Q: Are there any deleterious effects associated with the Keto-Diet?

Based upon limited data, the safety of a Keto-<a href="https://www.withpower.com/clinical-trials/diet">Diet</a> was rated 2 in our team's assessment. This is because Phase 2 trials do not provide evidence for efficacy and only minimal proof supporting its security.

Q: Are there any participation slots open for this clinical trial?

Clinicaltrials.gov indicates that this particular trial, which was initiated on April 1st 2023 and last updated on January 23rd of the same year, is not actively seeking patients. Nevertheless, 436 other trials are open for recruitment at present.

Q: How many settings is this study being implemented in?

This research study is currently in progress at 5 locations across the United States, including Los Angeles, San Francisco and Santa Monica. To reduce commuting burden for participants, it would be best to select a location closest to them.

Phase 2

Recruiting

Led By Jethro Hu, MD

Research Sponsored by Cedars-Sinai Medical Center

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 from baseline to 18 months

Awards & highlights

Study Summary

This trial is researching whether a Keto Diet could improve survival in glioblastoma patients.

Who is the study for?

This trial is for adults over 18 with newly diagnosed glioblastoma who haven't started chemotherapy or radiation. They must be able to perform daily activities well (KPS ≥ 70), read and understand English or Spanish, and commit to the study's requirements. Excluded are those with recurrent glioblastoma, certain genetic disorders, high steroid needs, pregnancy/nursing status, other experimental therapies, comorbidities that limit participation as per investigator's opinion, electronic medical implants unsafe for MRIs (with some exceptions), BMI < 21kg/m2 unless deemed safe by the investigator.Check my eligibility

What is being tested?

The study compares two diets in patients with glioblastoma: a Keto Diet versus a Standard Anti-Cancer Diet. Each participant will also receive standard cancer treatments alongside their assigned diet. The Keto Diet group will have an 18-week intervention monitored by research dietitians through daily ketone and glucose level checks.See study design

What are the potential side effects?

Potential side effects from the Keto Diet may include fatigue, constipation or diarrhea due to dietary changes, low blood sugar levels (hypoglycemia), nutrient deficiencies if not properly managed and possible increase in cholesterol levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 18 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

Overall survival

Secondary outcome measures

Cognitive performance 1

Cognitive performance 2

Health-related quality of life 1

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Keto-DietExperimental Treatment1 Intervention

Intensive 18-week Keto Diet intervention.

Group II: Standard Anti-Cancer DietPlacebo Group1 Intervention

Standard Anti-Cancer Diet with Dietitian support

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,684 Total Patients Enrolled

322 Trials studying Glioblastoma

22,945 Patients Enrolled for Glioblastoma

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,693 Total Patients Enrolled

5 Trials studying Glioblastoma

125 Patients Enrolled for Glioblastoma

Jethro Hu, MDPrincipal InvestigatorCedars-Sinai Medical Center

2 Previous Clinical Trials

60 Total Patients Enrolled

2 Trials studying Glioblastoma

60 Patients Enrolled for Glioblastoma

Media Library

Keto Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05708352 — Phase 2

Glioblastoma Research Study Groups: Standard Anti-Cancer Diet, Keto-Diet

Glioblastoma Clinical Trial 2023: Keto Diet Highlights & Side Effects. Trial Name: NCT05708352 — Phase 2

Keto Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708352 — Phase 2

Frequently Asked Questions

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

Are there any deleterious effects associated with the Keto-Diet?

"Based upon limited data, the safety of a Keto-Diet was rated 2 in our team's assessment. This is because Phase 2 trials do not provide evidence for efficacy and only minimal proof supporting its security."

Answered by AI

Are there any participation slots open for this clinical trial?

"Clinicaltrials.gov indicates that this particular trial, which was initiated on April 1st 2023 and last updated on January 23rd of the same year, is not actively seeking patients. Nevertheless, 436 other trials are open for recruitment at present."

Answered by AI

How many settings is this study being implemented in?

"This research study is currently in progress at 5 locations across the United States, including Los Angeles, San Francisco and Santa Monica. To reduce commuting burden for participants, it would be best to select a location closest to them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment

Jethro Hu 2023. "A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05708352.

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