Abstract
8018 Background: Dronabinol (MARINOL), synthetic tetrahydrocannabinol, binds to cannabinoid receptors and has antiemetic activity. To explore if this novel mechanism would be of benefit in delayed CINV, dronabinol was added to the prophylactic regimen for acute CINV and continued after chemotherapy.
METHODS:
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).
RESULTS:
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]
