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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33175
Enrollment
10
Registered
2010-02-02
Start date
2010-03-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse malignant brainstem glioma malignant brain tumour

Interventions

Ketogenic diet (first Classical version of the diet with shakes , soups and smoothies) after that the MCT version of the diet

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
determination of safety and feasibility of the ketogenic diet in children with recurrent of progressive pontine glioma during study period of 3 months

Secondary

MeasureTime frame
stabilisation of neurological functioning patient survival

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)