Dronabinol for the prevention of nausea from cyclophosphamide and/or adriamycin

BACKGROUND: Prevention of chemotherapy-induced nausea (CIN) remains challenging. Cannabinoids may reduce nausea. METHODS: Adult solid tumor patients receiving cyclophosphamide <1,500 mg/m2 (C) and/or doxorubicin>40 mg/m2 (A) were eligible. Patients could have received prior mildly emetogenic chemotherapy (EC). Patients were not eligible who were receiving other moderately or highly EC; were receiving cranial, abdominal, or pelvic radiotherapy; had CIV/CIN with previous chemotherapy; had habitual cannabinoid use; had other causes for nausea/vomiting besides chemotherapy; or were scheduled to receive other antiemetics. All patients received palonosetron 0.25 mg and dexamethasone 10 mg IV before chemotherapy. Patients were randomized double-blind to receive dronabinol 5 mg (D) or matching placebo (P) three times a day for 5 days. Nausea, vomiting, and toxicity data were collected daily for 5 days. RESULTS: Sixty-two patients were entered in the study: female/male, 61:1; White/Black/Hispanic/other, 45:14:2:1; median age (range), 58 years (29-76 years). No significant difference was noted in CIV dependent end points (including no vomiting, complete response, or complete protection) or in rescue medication use. However, patients receiving D had a shorter duration of nausea-mean number of days of nausea, 1.86 vs. 3.10 days (D vs. P, p=0.027)-and a trend toward greater frequency of no nausea, 37 vs. 17 % (D vs. P, p=0.143). Common toxicities included fatigue (D/P, 17:11), headache (D/P, 16:16), dizziness (D/P, 14:7), constipation (D/P, 14:11), and diarrhea (D/P, 13:6). CONCLUSION: Adding low-dose dronabinol to palonosetron and dexamethasone decreased the duration of chemotherapy-induced nausea in patients receiving cyclophosphamide and/or adriamycin.