Trial record 1 of 1 for:
jethro hu ketogenic
Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma
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| ClinicalTrials.gov Identifier: NCT03451799 |
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Recruitment Status :
Recruiting
First Posted : March 2, 2018
Last Update Posted : August 28, 2018
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Sponsor:
Jethro Hu
Information provided by (Responsible Party):
Jethro Hu, Cedars-Sinai Medical Center
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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 |
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 (Clinical Trial) |
| 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
Drug Information available for:
Temozolomide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ketogenic diet+radiation+temozolomide
Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide
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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 :
- 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.
Secondary Outcome Measures :
- 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
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:
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Glioblastoma Ketogenic diet Keto diet GBM |
Additional relevant MeSH terms:
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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |