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ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma.

Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. Electronic address: martin.voss@kgu.de. University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neurology (Edinger-Institute), University Hospital Frankfurt, Goethe University, Frankfurt, Germany. University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Neurosurgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Department of Medicine 1, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Department of Neurosurgery, HELIOS Hospital Erfurt, Erfurt, Germany. Department of Radiation Oncology, HELIOS Hospital Erfurt, Erfurt, Germany. Department of Radiation Oncology, University Hospital Tübingen, Tübingen, Germany. University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; Interdisciplinary Division of Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.

International journal of radiation oncology, biology, physics. 2020;(4):987-995
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Abstract

PURPOSE ERGO2 is the first randomized clinical trial on a calorically restricted ketogenic diet (KD) and intermittent fasting (KD-IF) in addition to reirradiation for recurrent malignant gliomas. METHODS AND MATERIALS Fifty patients were randomized 1:1 to reirradiation combined with either a calorically unrestricted diet or KD-IF. The KD-IF schedule included 3 days of KD (21-23 kcal/kg/d), followed by 3 days of fasting and again 3 days of KD. Primary endpoint was progression-free survival (PFS) at 6 months (PFS6). Secondary endpoints were PFS, local PFS, overall survival (OS), frequency of epileptic seizures, rate of ketosis and quality of life. RESULTS Four patients quit the trial before treatment and 3 patients stopped KD-IF prematurely. Of the 20 patients who completed KD-IF, 17 patients developed ketosis at day 6 and glucose levels declined significantly. KD-IF was well-tolerated with a modest weight loss of -2.1 ± 1.8 kg. No severe adverse events attributable to the diet occurred. PFS6 was not significantly different between the 2 groups (KD-IF: 20%; calorically unrestricted diet: 16%). Similarly, no difference in PFS, local PFS6, or OS was observable. Explorative analysis revealed that patients in the KD-IF group who had a glucose level of less than the median (83.5 mg/dL) on day 6 had significantly longer PFS and OS compared with those above the median (P < .05). CONCLUSIONS KD-IF is feasible and effective in inducing ketosis in heavily pretreated patients with recurrent glioma. However, the short schedule reported here failed to increase the efficacy of reirradiation. CLINICALTRIALS. GOV NUMBER NCT01754350.

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