Table 4. . Summary of ongoing clinical trials.
Study (year) | Location | Population condition | Target sample size | Dietary intervention(s) | Primary outcomes | Secondary outcomes | Expected date of completion |
---|---|---|---|---|---|---|---|
Ghodsi (2012) | Iran | Post Sx, CRT GB | 20 | ER MCT KD (50% MCT, ER to 25 kcal/kg/day) | Survival | Quality of life | Unknown |
Guimaraes Santos & Pereira da Fonseca (2016) | Brazil | Recurrent GB | 30 | KD vs control with intranasal administration of perillyl alcohol | Tumor size | Anthropometry | Unknown |
Jameson (2014) | New Zealand | Newly diagnosed GB | 20 | KD (<30 g CHO/day) | PFS | Ketosis treatment compliance Dietary compliance Food satisfaction SGA Adverse events |
Unknown |
Martin & Jenkinson (2017) | UK | Newly diagnosed GB | 12 | MKD (5% CHO, 80% fat) vs MCT KD (10% CHO, 75% fat [30% MCT]) | Retention | Enrolment Long term retention Dietary adjustments Self-reported compliance Calculated compliance MCT compliance Ketosis Dietetic time Protocol refinements Sample size estimations Quality of life Food acceptability Gastrointestinal side effects Biomarkers Anthropometry Completeness of data |
March 2019 |
Klein (2014) | USA | Recurrent GB | 6 | ER 4:1 KD (1600 kcals/day) vs standard diet | Overall survival PFS Adverse events |
Tolerability | August 2017 |
Klein (2016) | USA | Newly diagnosed GB | 6 | ER 4:1 KD (1600 kcals/day) | Safety | Efficacy Tolerability |
May 2017 |
Rieger & Steinbach (2012) | Germany | Recurrent GB | 50 | ER KD with IF (<60 g CHO/day) vs standard diet | PFS | Feasibility Safety Tolerability Overall survival Seizure frequency Ketosis Quality of life Depression Attention Response |
October 2017 |
Scheck (2014) | USA | Newly diagnosed GB | 14 | 4:1 KD reduced to MAD post CRT | Adverse events | Overall survival PFS Quality of life |
March 2017 (study ongoing, not recruiting) |
Schwartz (2012) | USA | Newly diagnosed GB | 12 | ER KD (20–25 kcals/kg/day) | Tumor size | None stated | July 2017 |
Song (2016) | China | Recurrent GB | 60 | KD vs standard diet | Adverse events | Chemotherapy sensitivity Overall survival Ketosis Quality of life |
December 2018 |
Strowd (2014) | USA | Post Sx, CRT GB | 25 | MAD with IF | Feasibility | Tolerability Biological activity Glucose levels Ketosis Anthropometry Seizure frequency |
November 2018 |
Vaisman (2010) | Israel | Recurrent GB | 40 | KD vs standard diet | Tumor size | Performance scale Quality of life |
March 2011 (last updated March 2010) |
CHO: Carbohydrate; CRT: Chemoradiotherapy; ER: Energy restriction; GB: Glioblastoma; IF: Intermittent fasting; KD: Ketogenic diet; MAD: Modified Atkins diet; MCT: Medium-chain triglyceride; MKD: Modified ketogenic diet; PFS: Progression-free survival; SD: Standard deviation; SGA: Subjective global assessment; Sx: Surgery.