Dronabinol and prochlorperazine alone and in combination as antiemetic agents for cancer chemotherapy.

Lane et al. ·American Journal of Clinical Oncology Impact 1.3

Mixed GRADE Moderate 37 citations

Samplen = 19 Pat.

Durationunclear

ControlProchlorperazine 10 mg p.o. q.i.d. plus…

EndpointDuration and severity of…

Blindingdoppelblind

DesignRCT (doppelblind, parallel)

Cannabinoidthc

Max. dose40.0 mg

Routeoral

Key finding

Dronabinol (alone or combined) showed significantly better efficacy against nausea and vomiting than prochlorperazine alone, but was associated with more CNS side effects.

Summary

n=19 (6+6+5 evaluable), double-blind multicenter RCT; dronabinol 10 mg vs. prochlorperazine 10 mg vs. combination in chemotherapy-induced nausea/vomiting; median duration and severity of nausea and vomiting episodes significantly lower in dronabinol groups vs. prochlorperazine alone; only 1/5 patients in the combination group vs. 3/6 each in the single-therapy groups suffered from nausea; side effects (sedation, dizziness) more frequent in dronabinol groups, but not significantly different.

PopulationCancer patients undergoing chemotherapy, n=19 (6 evaluable each in mono groups, 5 in combination group)

InterventionDronabinol 10 mg p.o. q.i.d. (alone or in combination with prochlorperazine 10 mg p.o. q.i.d.)

ControlProchlorperazine 10 mg p.o. q.i.d. plus placebo

OutcomeSignificantly shorter duration and lower severity per nausea episode as well as shorter duration per vomiting episode in the dronabinol groups vs. prochlorperazine alone (p significant; p for nausea prevalence n.s.)

Confidence in the evidence

Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding Double-blind

Effect size Mixed

Citations / year ★★★★★

Authors

Lane M, Smith FE, Sullivan RA, Plasse TF

DOI 10.1097/00000421-199012000-00006↗

Design: RCT (doppelblind, parallel)

Abstract

Nineteen patients receiving cancer chemotherapy were randomized in a double-blind fashion to receive either (a) dronabinol, 10 mg plus placebo q.i.d.; (b) prochlorperazine, 10 mg plus placebo q.i.d.; or (c) dronabinol plus prochlorperazine, each 10 mg q.i.d. There were six evaluable patients in each of the two single-agent groups and five in the combination group. The median duration and severity per episode of nausea was significantly greater in the group receiving prochlorperazine alone versus the other two groups. The median duration per episode of vomiting was also significantly greater in the prochlorperazine group than in the other two groups. The proportion of patients vomiting was the same in all groups; however, only one patient in the combination group versus three each in the single-agent groups experienced nausea (p = NS). The majority of side effects were associated with the CNS, including somnolence, dizziness, and confusion. Side effects were somewhat more common in both groups receiving dronabinol, though they were not statistically different from the side effects in the group receiving prochlorperazine as a single agent. Efficacy, as measured by duration of nausea and vomiting and by severity of nausea, was significantly greater in both groups receiving dronabinol.

The impediment to action advances action. — Marcus Aurelius