Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study (GBMXRT)
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|ClinicalTrials.gov Identifier: NCT02302235|
Recruitment Status : Recruiting
First Posted : November 26, 2014
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme of Brain||Other: Ketogenic Diet Other: Standardized Diet||Phase 2|
Primary aims of the study will be to 1) To evaluate efficacy of ketogenic diet as adjunctive treatment of radiation treatment in glioblastoma multiforme. 2) To evaluate the safety of ketogenic diet as adjunctive treatment of radiation treatment in glioblastoma multiforme. Secondary aim will be to evaluate tolerability of ketogenic diet as adjunctive treatment of radiation treatment in glioblastoma multiforme.
Participants will be seen at one, 2 weeks, and 4 weeks after KG diet initiation, and then monthly until month 6 after diet initiation, then every 2 months until 2 years after treatment initiation or death, then every 3 months until 3 years after treatment initiation or death. KD treatment will last for 6 months or until exit criteria are met, whichever comes first. Exit criteria are the primary outcome measures, the first of either (a) MRI tumor progression or (b) death. Secondary outcome measures will include treatment compliance, hunger scale scores, fasting serum glucose and BOH levels and occurrence of adverse events.
Patients with documented tumor progression will receive standard care for progressive GBM as directed by their treating oncologist, independent of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Ketogenic Diet
Treatment will consist of ketogenic diet. KGD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction. Diet will be started at the time of initiation of radiation treatment.
Other: Standardized Diet
Participants with GBM treated with radiation and temozolomide after surgical debulking treatment. The subjects will be taken standard diet in a 1:1 ratio. Diet will be started at the time of initiation of radiation treatment.
The subjects will be taken standard diet in a 1:1 ratio.
Other: Ketogenic Diet
Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction.
Other Name: KGD
- survival time [ Time Frame: 6 months ]We hope to achieve a substantial difference in both survival time and time to recurrence between the KD and non-KD treatment groups. Survival time of 3 years from treatment initiation and tumor progression-free time of 2.5 years from treatment initiation would be extraordinary compared to historical data.
- time to radiological (MRI) tumor progression [ Time Frame: 6 months ]MRI outcome will be assessed by the radiographic assessment in neuro-oncology criteria based on contrast-enhanced cranial MRI scans evaluating measureable disease, measured as the sum of products of perpendicular diameters (bi-dimensional measurements) of all measurable enhancing lesions and non-measurable disease.
- The incidence of treatment-emergent adverse events during treatment [ Time Frame: 6 months ]Incidence of treatment-emergent adverse events changes in laboratory evaluations, changes in physical examination findings will be compared between the KD and control treatment groups
- Tolerability of ketogenic diet: Rate of early discontinuation of subjects from the diet because of intolerability, defined as unwillingness by the subject to continue with the diet because of possible diet related side effects [ Time Frame: 6 months ]Rate of early discontinuation of subjects from the diet because of intolerability, defined as unwillingness by the subject to continue with the diet because of possible diet related side effects will be evaluated using descriptive statistics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302235
|Contact: Pavel Klein, M.D.||firstname.lastname@example.org|
|Contact: Ivana Tyrlikova, M.D.||email@example.com|
|United States, Maryland|
|MidAtlantic Epilepsy and Sleep Center||Recruiting|
|Bethesda, Maryland, United States, 20817|
|Contact: Ivana Tyrlikova, MD 301-530-9744 firstname.lastname@example.org|
|Contact: Pavel Klein, MD 301-704-4925 email@example.com|
|Principal Investigator: Pavel Klein, MD|
|Principal Investigator:||Pavel Klein, M.D.||Mid-Atlantic Epilepsy and Sleep Center|