Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With … (NCT03451799) | Clinical Trial Compass
CompletedPhase 1
Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma
United States21 participantsStarted 2018-04-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …