Ketogenic Diet in Children With Malignant or Recurrent/Refractory Brain Tumor

NCT03328858 | Terminated

• 1 other identifier: MCH05817
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of the ketogenic diet on tumor size and quality of life in pediatric patients with malignant or recurrent/refractory brain tumors.

Conditions

Brain Tumors

Keywords

Ketogenic Diet, brain tumors

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  To evaluate the overall response rate of subjects with malignant or refractory brain tumors receiving dietary therapy with the ketogenic diet

  one year

Secondary Outcomes (4)

• Quality of Life Measures

  one year

• Ketosis Levels

  one year

• Blood Glucose Levels

  one year

• Correlation of ketosis levels and ketogenic diet

  one year

Study Arms (1)

Ketogenic Diet

OTHER

Participants will be provided a consultation with a ketogenic dietitian, and test the tolerance to the diet in an inpatient mode

Other: Ketogenic Diet

Interventions

Ketogenic Diet OTHER

Once tolerance to the diet has been assessed, participants will be placed in the ketogenic diet, followed-up every three months until the one year completion.

Ketogenic Diet

Eligibility Criteria

• Age: 12 Months - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis Medulloblastoma, high-grade glioma, low-grade glioma, and ependymoma are eligible. Other central nervous system tumors may be considered for treatment at discretion of investigator. Pathology is required unless diffuse intrinsic pontine glioma or optic pathway tumor. The patient should have failed first line therapy and be considered refractory, relapsed, or recurrent. Exceptions are Grade III and Grade IV gliomas including brain stem gliomas who can be enrolled at initial diagnosis.
• Prior Therapy Patients should have already had first line standard of care therapy, unless their initial diagnosis is high grade glioma or DIPG in which case they are eligible. Patients with high grade glioma can be enrolled after the completion of initial radiation. Investigator discretion may also be used.
• Organ Function Requirements A. Functioning gastrointestinal system, i.e. ability to chew and swallow or alternative means of nutrition therapy such as a gastrostomy or jejunostomy tube B. SGPT (ALT) \< 3 x upper normal limit; Total Bilirubin ≤ 2 x upper normal limit C. No active pancreatitis D. No arrhythmia or prolonged QT.

You may not qualify if:

• History of cardiac arrhythmia
• Patient unable to chew/swallow and who do not consent to alternative methods of nutrition support, e.g. nasogastric or nasoduodenal tube, or gastrostomy or jejunostomy tube placement.

Sponsors & Collaborators

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: lead

Study Sites (1)

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Related Publications (6)

• Gasior M, Rogawski MA, Hartman AL. Neuroprotective and disease-modifying effects of the ketogenic diet. Behav Pharmacol. 2006 Sep;17(5-6):431-9. doi: 10.1097/00008877-200609000-00009.

  PMID: 16940764 BACKGROUND

• Neal EG, Chaffe H, Schwartz RH, Lawson MS, Edwards N, Fitzsimmons G, Whitney A, Cross JH. A randomized trial of classical and medium-chain triglyceride ketogenic diets in the treatment of childhood epilepsy. Epilepsia. 2009 May;50(5):1109-17. doi: 10.1111/j.1528-1167.2008.01870.x. Epub 2008 Nov 19.

  PMID: 19054400 BACKGROUND

• Kossoff EH. More fat and fewer seizures: dietary therapies for epilepsy. Lancet Neurol. 2004 Jul;3(7):415-20. doi: 10.1016/S1474-4422(04)00807-5.

  PMID: 15207798 BACKGROUND

• Lussier DM, Woolf EC, Johnson JL, Brooks KS, Blattman JN, Scheck AC. Enhanced immunity in a mouse model of malignant glioma is mediated by a therapeutic ketogenic diet. BMC Cancer. 2016 May 13;16:310. doi: 10.1186/s12885-016-2337-7.

  PMID: 27178315 BACKGROUND

• Vidone M, Clima R, Santorsola M, Calabrese C, Girolimetti G, Kurelac I, Amato LB, Iommarini L, Trevisan E, Leone M, Soffietti R, Morra I, Faccani G, Attimonelli M, Porcelli AM, Gasparre G. A comprehensive characterization of mitochondrial DNA mutations in glioblastoma multiforme. Int J Biochem Cell Biol. 2015 Jun;63:46-54. doi: 10.1016/j.biocel.2015.01.027. Epub 2015 Feb 7.

  PMID: 25668474 BACKGROUND

• Nebeling LC, Miraldi F, Shurin SB, Lerner E. Effects of a ketogenic diet on tumor metabolism and nutritional status in pediatric oncology patients: two case reports. J Am Coll Nutr. 1995 Apr;14(2):202-8. doi: 10.1080/07315724.1995.10718495.

  PMID: 7790697 BACKGROUND

Related Links

• Nicklaus Children's Hospital

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jennifer Caceres, MS, RDN

  Nicklaus Children's Hospital

  PRINCIPAL INVESTIGATOR

• Ziad Khatib, MD

  Nicklaus Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ketogenic Diet will be initiated as inpatient, once all necessary studies are obtained and reviewed. The "classic ketogenic diet" will be initiated, and once ketosis is reached and patient demonstrates tolerance to diet he/she will be discharged home. Follow-up visits will be necessary up to 1 year.

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 1, 2017
• Study Start: November 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)