Ketogenic Diet for Recurrent Glioblastoma
Atslēgvārdi
Abstrakts
Apraksts
Increased glycolysis and reduced oxidative phosphorylation is a characteristic property of many tumors. A change of nutrition by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and therefore inhibit tumor growth. Standard treatment for glioblastoma includes resection, irradiation and temozolomide chemotherapy. If there is tumor recurrence, no standard therapy is established. Therapeutic options in this situation include resection, irradiation or another chemotherapy. However, some patients cannot be treated in this situation, because none of the available treatment options seems reasonable or applicable, for example if no additional chemotherapy can be started at the time of recurrence due to myelosuppression. The pilot study examines whether in this situation a ketogenic diet can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.
Datumi
| Pēdējoreiz pārbaudīts: | 03/31/2014 |
| Pirmais iesniegtais: | 12/16/2007 |
| Paredzētā reģistrācija iesniegta: | 12/16/2007 |
| Pirmais izlikts: | 12/17/2007 |
| Pēdējais atjauninājums iesniegts: | 04/15/2014 |
| Pēdējā atjaunināšana ievietota: | 05/01/2014 |
| Pirmo rezultātu iesniegšanas datums: | 06/17/2013 |
| Pirmo QC rezultātu iesniegšanas datums: | 11/17/2013 |
| Pirmo publicēto rezultātu datums: | 12/12/2013 |
| Faktiskais studiju sākuma datums: | 11/30/2007 |
| Paredzamais primārās pabeigšanas datums: | 01/31/2010 |
| Paredzamais pētījuma pabeigšanas datums: | 01/31/2010 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Dietary Supplement: 1
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Experimental: 1 ketogenic diet | Dietary Supplement: 1 ketogenic diet, dietary supplementary products provided by TAVARLIN |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: - age >= 18 years - histological diagnosis of glioblastoma or gliosarcoma - on MRI measurable tumor - interval of at least 6 months after primary resection - completed radiotherapy, interval of at least 3 months after completion of radiotherapy - relapse during or after temozolomide chemotherapy, other chemotherapy not possible, not reasonable or not wanted by the patient - Karnofsky-Index >= 60%, ECOG <= 2 - life expectancy of at least 12 weeks - creatinine <= 1.5 mg/dl, urea <= 50 mg/dl - INR <= 1,5, GOT <= 7 x of normal value, GPT <= 7 x of normal value Exclusion Criteria: - bowel obstruction or subileus - diabetes mellitus, HbA1c > 6,1 % - heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial fibrillation - acute infection - conditions that may strongly reduce compliance to the diet or increase risk of the diet - dementia or clinically relevant alterations of the mental state which interfere with the applicability of the diet |
Rezultāts
Primārie rezultāti
1. Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability [until progression for up to 12 months]
Sekundārie iznākuma mērījumi
1. Progression-free-survival [until progression for up to 12 months]
2. Overall Survival [death/last contact, an average of about 1 year]
3. Frequency of Seizures [while on study treatment for up to 12 months]
4. Ketosis [while on study treatment for up to 12 months]
5. Quality of Life [while on study treatment for up to 12 months]
