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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451799
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jethro Hu, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE March 2, 2018
Last Update Posted Date August 28, 2018
Actual Study Start Date  ICMJE April 13, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
  • 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.
  • Safety of the intervention [ Time Frame: Four months ]
    Number of related adverse events based on CTCAE v.5.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
  • 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.
  • Safety of the intervention [ Time Frame: Four months ]
    Number of related adverse events based on CTCAE v.4.
Change History Complete list of historical versions of study NCT03451799 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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.
  • Overall Survival [ Time Frame: Sixty months ]
    Time (in months) from initiation of the ketogenic diet to date of death
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
  • 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.
  • Overall Survival [ Time Frame: Sixty months ]
    Time (in months) from initiation of the ketogenic diet to date of death
  • 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)
  • 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
  • Quality of Life (four months) [ Time Frame: Four months ]
    Mean change in overall Quality of Life from baseline to 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma
Official Title  ICMJE 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
Brief Summary Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Detailed Description Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will place patients on a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption. Dietitians will provide guidance and teaching of the diet, as well as, monitoring and diet adjustment to ensure metabolic ketosis. Dietitians and study physicians (and their staff) will monitor subjects for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm, prospective cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • GBM
  • Glioblastoma
Intervention  ICMJE
  • Other: Ketogenic Diet
    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.
  • Radiation: Standard-of-care radiation
    Patients will receive standard-of-care radiation. Radiation is not protocol directed.
  • Drug: Standard-of-care Temozolomide
    Patients will receive standard-of-care temozolomide. Temozolomide is not protocol directed.
Study Arms  ICMJE Experimental: Ketogenic diet+radiation+temozolomide
Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide
Interventions:
  • Other: Ketogenic Diet
  • Radiation: Standard-of-care radiation
  • Drug: Standard-of-care Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 3.1.1 Adults (age ≥ 18 years)
  • 3.1.2 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.
  • 3.1.3 Being seen for treatment of GBM at Cedars-Sinai Medical Center
  • 3.1.4 Patients on low and managed doses of steroids are permitted. Up to 8 mg dexamethasone or steroid equivalent.

Exclusion Criteria:

  • 3.2.1 Karnofsky Performance Status of <70 as deemed by physician or equivalent
  • 3.2.2 Body Mass Index of <24 (rounded to nearest integer)
  • 3.2.3 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
  • 3.2.4 Pregnancy
  • 3.2.5 Patients who are vegan or vegetarian will be excluded, as the ketogenic diet includes foods that may interfere with these preferences
  • 3.2.6 Patients on high doses of steroids will be excluded
  • 3.2.7 Inability to adhere to the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Lockshon 424-315-2219 Laura.Lockshon@cshs.org
Contact: Dana Levin 310-423-0333 Dana.Levin@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03451799
Other Study ID Numbers  ICMJE IIT2016-17-HU-KETORADTMZ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jethro Hu, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Jethro Hu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jethro Hu, MD Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
PRS Account Cedars-Sinai Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP