Safety and feasibility of the ketogenic diet in therapy resistand paediatric recurrent or progressive pontine glioma, a pilot study

Phase 2

Recruiting

• Conditions: diffuse malignant brainstem glioma; malignant brain tumour; 10029211

• Registration Number: NL-OMON33175
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- recurrent or progressive pons glioma
- 1-18 years of age
- failure of treatment with radiotherapy and Temozolomide and no therapeutic options left
- good Dutch reading and writing (parents of caregivers)
- Informed Consent of parents/care givers and/or the child (when >12)
- willingness of children younger than 12 years to participate in the study

Exclusion Criteria

- < 1 year or >17 year of age
- use of Temozolomide or other chemotherapeutic drug
- language barrier (parents or caregivers)
- current treatment with steroids of treated within 3 weeks before start of the study
- fatty acid disorders (like MCAD)
- Hypertrigyceridemia (> 10mmol/l)
- kidney stones
- diabetes mellitus
- pancreatitis
- gastro intestinal problems like persistent diarrhoea
- parents unable to handel dietary instructions
NB: use of tube feeding is NOT an exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>determination of safety and feasibility of the ketogenic diet in children with<br /><br>recurrent of progressive pontine glioma during study period of 3 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>stabilisation of neurological functioning<br /><br>patient survival </p><br>