- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03451799
Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma
IIT2016-17-HU-KETORADTMZ: A Phase 1 Study of a 4-month Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Newly/Recently Diagnosed Glioblastoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (age ≥ 18 years)
- Newly or recently diagnosed glioblastoma. Patients may enroll in the study from the time of diagnosis (prior to the initiation of standard-of-care chemoradiation) up until the initiation of post-radiation adjuvant chemotherapy (typically approximately 3-4 weeks after the completion of radiation therapy). Overall, this provides a window of approximately 3 months from the time of diagnosis for patients to enroll in this study. No recurrent glioblastoma is allowed on trial.
- Being seen for treatment of glioblastoma at Cedars-Sinai Medical Center. Note: Okay if patients receiving chemotherapy or radiation therapy at another facility
- Patients on low and managed doses of steroids are permitted. Up to 8 mg dexamethasone or steroid equivalent.
Exclusion Criteria:
- Karnofsky Performance Status of <70 as deemed by physician or equivalent
- Body Mass Index of <22 kg/m2 (rounded to nearest integer)
- Patients with disorders that affect lipid metabolism such as pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, Beta-Oxidation Defects
- Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
- Pregnant, nursing, or implanted with an intrauterine device (IUD) that is not MR compatible
- Patients who are vegan or vegetarian will be excluded, as the ketogenic diet includes foods that may interfere with these preferences
- Patients on high doses of steroids will be excluded
- Patients currently receiving experimental therapeutic therapy will be excluded from the trial. Note: Off-label therapy use is permitted
- Inability to adhere to the protocol
- Patients with history of allergic reactions to surgical steel or elastomer/rubber are excluded from the activity monitor portion of the study. Because the activity monitor uses a Bluetooth low energy Transceiver, individuals using pacemakers, implantable cardiac defibrillators, neuro-stimulation devices, cochlear implants, hearing aids, or other electronic medical equipment should also be excluded from wearing the activity monitor. They can still use the Aria scale to record weight.
- Patients with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps, that are not magnetic resonance imaging/positron emission tomography (MRI/PET) compatible.
- Patients with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
- Patients unable to tolerate MRI/PET imaging secondary to an inability to lie supine or severe claustrophobia as assessed by the treating physician or principal investigator.
- Patients unable to lie still, hold their breath, or follow imaging procedure instructions as assessed by the treating physician or PI.
- Patients whose most recent renal function test does not meet Cedars-Sinai Medical center standard of care MRI contrast protocol requirements (glomerular filtration rate <45ml/min).
- Patients with a known allergy to Fludeoxyglucose F18 (F18-FDG) radioactive tracer or gadolinium-based contrast agent.
- Patients with allergy to animal dander or animal-instigated asthma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketogenic diet+radiation+temozolomide
Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide
|
A 4-month ketogenic diet will be supervised and monitored by the study investigators.
Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis.
Patients will receive standard-of-care radiation.
Radiation is not protocol directed.
Patients will receive standard-of-care temozolomide.
Temozolomide is not protocol directed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the intervention
Time Frame: Four Months
|
Proportion of participants experiencing a 10% decrease in weight or body mass index AND have a BMI <18.5 within one month from initiation of the ketogenic diet.
|
Four Months
|
Safety of the intervention
Time Frame: Four months
|
Number of related adverse events based on CTCAE v.5.
|
Four months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the intervention
Time Frame: Four Months
|
Proportion of enrolled patients able to maintain blood ketone levels >0.3 mM for over 50% of days on study starting 2 weeks after initiation of the ketogenic diet.
|
Four Months
|
Overall Survival
Time Frame: Sixty months
|
Time (in months) from initiation of the ketogenic diet to date of death
|
Sixty months
|
Time-to-progression
Time Frame: Four Months
|
Time (in months) from baseline to progressive disease over study duration (estimated 4 months) - measured by RANO criteria (standard of care brain MRI) |
Four Months
|
Quality of Life (two months)
Time Frame: Two months
|
Mean change in overall Quality of Life from baseline to two months. -Quality of Life measured using EORTC QLQ-C30 global score |
Two months
|
Quality of Life (four months)
Time Frame: Four months
|
Mean change in overall Quality of Life from baseline to four months. -Quality of Life measured using EORTC QLQ-C30 global score |
Four months
|
Cognitive function (Hopkins Verbal Learning Test-Revised)
Time Frame: Four months
|
Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Hopkins Verbal learning Test-Revised |
Four months
|
Cognitive function (Trail Making Test)
Time Frame: Four months
|
Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Trail Making Test |
Four months
|
Cognitive function (Controlled Word Association Test)
Time Frame: Four months
|
Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Controlled Word Association Test |
Four months
|
Cognitive function (Montreal Cognitive Assessment)
Time Frame: Four months
|
Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Montreal Cognitive Assessment |
Four months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jethro Hu, MD, Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- IIT2016-17-HU-KETORADTMZ
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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