Subjects receiving moderate to high emetogenic chemotherapy were randomized in this double-blind, placebo-controlled, flexible-dose study. All subjects received dexamethasone 20mg PO and ondansetron 16mg IV prior to chemotherapy. Subjects in the dronabinol (D), ondansetron (O) and dronabinol plus ondansetron (DO) groups also received dronabinol 2.5mg pre- and post-chemotherapy (Day 1); the placebo (P) group did not. Treatment continued through Day 5. Adverse events (AEs) were coded using the MedDRA dictionary. No statistical testing was conducted on AE rates.
All 64 randomized subjects were in the safety population.
Dronabinol was well tolerated and resulted in few terminations due to adverse events. The low rate of CNS-related adverse events following D treatment may make it a suitable alternative to serotonin antagonist therapy for delayed CINV. [Figure: see text] [Table: see text].
- PMID: 27946950
- [PubMed – in process]