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ERGO2: ketogenic diet and fasting during re-irradiation of recurrent glioma

The only randomised trial of a ketogenic diet in brain tumours found no benefit. Patients could follow the diet and their ketone levels rose, but progression came just as quickly.

50 patients were randomised 1:1. The intervention was feasible and safe: glucose fell and ketones rose as intended, and the diet was well tolerated over nine days. Progression-free survival at 6 months, the primary endpoint, did not differ (20% vs 16%; median PFS 3.2 vs 3.4 months), nor did overall survival (median 11.1 vs 10.5 months). The trial is small and the dietary exposure brief, so it cannot exclude a benefit from sustained ketosis; equally, longer feasibility studies (KETOCAN, modified Atkins with standard chemoradiation) show adherence declining by three months. Together they define the current state: ketogenic diets in glioma are feasible, unproven, and widely promoted to patients as if they were not.

Setting
Recurrent glioblastoma and other malignant gliomas undergoing re-irradiation: 6-day calorie-restricted ketogenic diet plus 3-day fasting during radiotherapy vs standard diet
Phase
Phase 2
Sponsor
Goethe University Frankfurt
Registry
Headline result
6-month PFS 20% vs 16%; median OS 11.1 vs 10.5 months; no benefit.
Reported
2020
Enrolled
50
Replication
No adequately powered trial exists. Feasibility studies concordant on tolerability, silent on efficacy.

Outcomes

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In plain words
What these results mean for people, not percentages
50 people took part
Progression-free survival at 6 monthsprimarysurrogate endpoint
  • 20 vs 16 out of 100 alive without the cancer growing at 6 months with Ketogenic diet + fasting compared with Standard diet; 4 more per 100.
  • Roughly one extra person helped for every 25 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Recurrent glioblastoma and other malignant gliomas undergoing re-irradiation: 6-day calorie-restricted ketogenic diet plus 3-day fasting during radiotherapy vs standard diet. People in a different situation may not see the same effect.
  • Only 50 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

50 participants enrolled.

Progression-free survival at 6 monthsprimary
Ketogenic diet + fasting20 of 100
n = 25
Standard diet16 of 100
n = 25
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival at 6 monthsprimaryKetogenic diet + fasting2520%link
Standard diet2516%
Replication
No adequately powered trial exists. Feasibility studies concordant on tolerability, silent on efficacy.

Connected

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