Subjects receiving moderate to high emetogenic chemotherapy were randomized to double-blind, placebo-controlled, flexible-dose treatment. All subjects received dexamethasone 20mg PO and ondansetron 16mg IV pre-chemotherapy. Subjects receiving dronabinol (D), ondansetron (O) or dronabinol+ondansetron (DO) also received dronabinol 2.5 mg pre- and post-chemotherapy (Day 1); the placebo (P) group did not. Treatment continued through Day 5; symptoms were assessed daily. Primary efficacy was total response (TR- nausea intensity <5mm on visual analog scale [VAS], no vomiting/retching, no rescue antiemetic). Secondary measures included nausea occurrence, nausea intensity (VAS) and vomiting/retching episodes. Active treatments were compared with each other and P (Days 2-5) and significance was p≤0.05(unadjusted).
Sixty-four subjects were randomized and 61 analyzed for efficacy. TR was comparable for the D and O groups. All active treatments were statistically better than P in absence of nausea and nausea intensity. Nausea intensity and vomiting/retching were lowest in group D. There were no statistical differences among active treatments. Study treatments were well tolerated. Efficacy at Endpoint (LOCF) Conclusions: Dronabinol was comparable to ondansetron in total response and but was more effective in reducing nausea intensity and vomiting/retching. Results for the combination of DO were similar to either agent alone. These results support conducting a larger study since D could become an attractive alternative to serotonin receptor antagonists in treating delayed CINV. [Figure: see text] [Table: see text].
- PMID: 27946578
- [PubMed – in process]