Phase 1
N=20
Ketogenic Diet for Recurrent Glioblastoma
Recurrent Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT00575146 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability — 15 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAVARLIN (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital Tuebingen
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability |
15 | — |
| SECONDARY Progression-free-survival |
5 | — |
| SECONDARY Overall Survival |
32 | — |
| SECONDARY Frequency of Seizures |
— | — |
| SECONDARY Ketosis |
— | — |
| SECONDARY Quality of Life |
— | — |
Summary
To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00575146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.