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Alkylating agents

Ketogenic diet for Brain Tumor

N/A

Waitlist Available

Led By Andrew Cluster, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial will develop a sex-specific diet-based intervention for gliomas (a type of brain tumor), and use metabolomics tools and FDG-PET imaging to validate the diet's effectiveness.

Eligible Conditions

Brain Tumor

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility of combining a ketogenic diet with chemotherapy in children with relapsed brain tumors as measured by if at least 80% of the patients comply with the intervention

Brain

Secondary outcome measures

Tolerability of combining a ketogenic diet with chemotherapy in male children with relapsed brain tumors versus female children with relapsed brain tumors as measured by toxicity

Tumor response of male children with relapsed brain tumors to a ketogenic diet combined with chemotherapy versus female children with relapsed brain tumors as measured by progression-free survival (PFS)

Side effects data

From 2011 Phase 3 trial • 170 Patients • NCT00002766

17%

Fatigue

16%

Hypokalemia

15%

Febrile neutropenia

15%

Hypophosphatemia

13%

Pain, other

13%

Abdominal pain/cramping

11%

Stomatitis/pharyngitis

Thrombosis

Dyspnea

Hypomagnesemia

Dizziness

Bilirubin

Prothrombin Time

Vision-blurred vision

SGPT (ALT)

Hyponatremia

Ileus (or neuroconstipation)

Anorexia

Infection/Febrible Neutrophil-Other

Hemorrhage, other

Platelets

Neuropathy-motor

infection

Pulmonary, other

Renal failure

Dehydration

Adult respiratory disorder

Diarrhea

Gastrointestinal, other

Epistaxis

Constipation

Leukocytes

Dermatology, skin other

Neutrophils (Leukemia)

Chest pain

Syncope

Supraventricular tachycardia

Headache

disseminated intravascular coagulation

Cardiovascular, Arrhythmia other

Ascites

ALT, SGPT

Pancreatitis

Supravent arrhythmia

Neutrophils

100%

80%

60%

40%

20%

Study treatment Arm

L-20

All-2

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketogenic DietExperimental Treatment2 Interventions

Caregivers (and participating children) attend intro ketogenic diet class (4 - 30 min lectures) Clinic visit with neurologist, nurse, and dietitian prior to hospital admission and then once every 3 months Laboratory studies prior to hospital admission and then at each follow-up visit Hospital admission (3-5 day) to start the ketogenic diet Standard of care chemotherapy with BCNU for up to 2 years Ketogenic diet can continue for up to 2 years

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BCNU

1996

Completed Phase 3

~1620

Ketogenic diet

2020

N/A

~680

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,707 Total Patients Enrolled

Andrew Cluster, M.D.Principal InvestigatorWashington University School of Medicine

2 Previous Clinical Trials

34 Total Patients Enrolled

Frequently Asked Questions

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

Are participants currently being enrolled in this research study?

"Yes, the data hosted on clinicaltrials.gov indicates this medical trial is in full swing. It was first posted on May 1st 2019 and has been recently refreshed as of July 27th 2022. The study aims to recruit 15 subjects at a single site."

Answered by AI

What is the current enrolment for this trial?

"Affirmative. Information found on clinicaltrials.gov tells us that this medical test was initially uploaded to the website in May of 2019 and is presently enrolling 15 individuals across a single site, with its last update occurring on July 27th 2022."

Answered by AI

What health conditions typically respond to a Ketogenic diet regimen?

"Ketogenic diets are frequently prescribed to patients with medulloblastomas, and may be used in the treatment of hodgkin disease, brain tumours, and glioblastoma multiforme (GBM)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis

2019. "Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03591861.