In this arm, trial participants receive the intervention that is being tested, skullremodeling surgery. This is in combination with tumor treating fields and best practice medical treatment.

In this arm, the trial participant receives tumor treating fields and best practice medical treatment.
This serves as an active comparative control arm to the intervention.

Recurrent Glioblastoma

Strategically placed cranial burrholes in order to improve the TTField "dose" focally in the tumor.

Skullremodeling surgery

Tumor treating fields combined with best medical treatment.

Control

Aarhus University Hospital

Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery)

Enhancing Tumor Treating Fields for Recurrent Glioblastoma With Targeted and Individualised Skullremodeling Surgery: A Multi-center Randomized Phase 2 Trial

Overall objective response rate assessed by modified RANO criteria

Standardised and verified questions related to quality of life to cancer and brain tumor patients. Quality of life is rated by the patients own thoughts about the current situation and future and also the presence or absence of the most common symptoms in cancer and brain tumors. Rated from a scale 1-4 (none to a lot) and 1-7 scale (very poor to very good).

Adverse events / Safety. All adverse events observed by personnel or reported by trial participant.

All data published will be available upon request. Study protocol will be published.

Anders Rosendal Korshøj

Principal Investigator, Associate Professor

NovoCure GmbH

Odense University Hospital

Patients will be randomized 1:1 to one of two study arms to receive either, 1) skullremodeling-surgery, TTFields and best practice medical oncological therapy (interventional arm), or 2) TTFields and best practice medical oncological therapy alone (control arm).

Skullremodeling surgery prevents the participant, careprovider and investigator to be blinded to the randomization.
The outcome assessors (statisticians) will be blinded when analysing the data.

8 weeks of 25 g/day of milled chia supplemented-isocaloric diet

Non-Alcoholic Fatty Liver Disease

Dietary Modification

8 weeks of an isocaloric diet supplemented with 25 g/day of milled chia

Milled chia seeds

Chia Supplementation and Non Alcoholic Fatty Liver Disease

Effect of a Chia Supplemented Diet (Salvia Hispanica) on the Cardiometabolic Risk Profile in Patients With NAFLD (Non Alcoholic Fatty Liver Disease)

To assess the effect of 25 g/day of milled chia in 25 patients with NAFLD.Improvement of LSAI (liver spleen attenuation index) measured by computed tomography In a single-arm experimental design study

Increase in Alpha linolenic acid with chia supplemented diet. Measured by gas chromatography.

Improvement of lipid parameters (total colesterol, LDL-C, triglycerides, HDL-C) including free fatty acids

arnold-chiari malformation/пролив

Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery)

Chia Supplementation and Non Alcoholic Fatty Liver Disease

Најкомплетната база на податоци за лековити билки поддржана од науката