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

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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

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.

Condition or disease Intervention/treatment Phase
GBM Glioblastoma Other: Ketogenic Diet Radiation: Standard-of-care radiation Drug: Standard-of-care Temozolomide Phase 1

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 : Interventional
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, prospective cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketogenic diet+radiation+temozolomide
Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide
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.




Primary Outcome Measures :
  1. 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.

  2. Safety of the intervention [ Time Frame: Four months ]
    Number of related adverse events based on CTCAE v.5.


Secondary Outcome Measures :
  1. 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.

  2. Overall Survival [ Time Frame: Sixty months ]
    Time (in months) from initiation of the ketogenic diet to date of death

  3. 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)


  4. 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


  5. 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


  6. 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


  7. 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


  8. 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


  9. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03451799


Contacts
Contact: Laura Lockshon 424-315-2219 Laura.Lockshon@cshs.org
Contact: Dana Levin 310-423-0333 Dana.Levin@cshs.org

Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Laura Lockshon    424-315-2219    Laura.Lockshon@cshs.org   
Principal Investigator: Jethro Hu, MD         
Sponsors and Collaborators
Jethro Hu
Investigators
Principal Investigator: Jethro Hu, MD Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Responsible Party: Jethro Hu, Principal Investigator, Faculty, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03451799     History of Changes
Other Study ID Numbers: IIT2016-17-HU-KETORADTMZ
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jethro Hu, Cedars-Sinai Medical Center:
Glioblastoma
Ketogenic diet
Keto diet
GBM

Additional relevant MeSH terms:
Glioma
Glioblastoma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents