Delta tocotrienol as a supplement to FOLFOXIRI in first-line treatment of metastatic colorectal cancer. A randomized, double-blind, placebo-controlled phase II study

Study answer

What this study found

Delta-tocotrienol did not significantly improve the primary endpoint of time to first non-planned hospitalization or death. Median time to first hospitalization or death was not reached with delta-tocotrienol versus 3.7 months with placebo, with HR 0.70 (95% CI 0.36-1.36, p=0.29); the 7-month event proportion was 42% versus 57% (p=0.15). Toxicity was broadly similar, with febrile neutropenia in 4 patients in each group and no grade 3 or 4 peripheral sensory neuropathy, but oxaliplatin dose reductions were less frequent with delta-tocotrienol (47% vs 71%, p=0.047). Progression-free survival…

Study & population

Randomized, double-blind, placebo-controlled phase II trial at a single center in Denmark.

Intervention

Delta-tocotrienol was given orally as capsules at 300 mg three times daily, with each capsule containing 90% delta-tocotrienol and 10% gamma-tocotrienol.

Key limitation

This was a small phase II, single-center study, which limits precision and generalizability.

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Original abstract