Efficacy of tetrahydrocannabinol in patients refractory to standard antiemetic therapy.

McCabe et al. ·Investigational New Drugs Impact 3.6

Clear benefit GRADE Moderate 69 citations

Samplen = 36 Pat.

Durationunclear

ControlProchlorperazine 10 mg oral

EndpointAntiemetic response rate

Blindingunklar

DesignRandomized Controlled Trial (crossover)

Cannabinoidthc

Routeoral

Key finding

THC reduced nausea and vomiting in 64% of patients (23/36) compared to 3% under prochlorperazine (1/36).

Summary

Randomised crossover study (n=36) in cancer patients with refractory chemotherapy-induced nausea: oral THC (15 mg/m²) reduced nausea and vomiting in 23/36 (64%) of patients vs. 1/36 (3%) under prochlorperazine. All patients reported transient sensory changes; dysphoria occurred in 17/36 cases. Recommended starting dose 5 mg/m².

PopulationCancer patients with chemotherapy-induced nausea and vomiting, refractory to standard antiemetics, n=36

InterventionOral delta-9-tetrahydrocannabinol (THC) 15 mg/m²

ControlProchlorperazine (PCZ) 10 mg oral

OutcomeTHC reduced nausea and vomiting in 23/36 (64%) vs. 1/36 under PCZ

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 —

Effect size Clear benefit

Citations / year ★★★★★

Authors

McCabe M, Smith FP, Macdonald JS, Woolley PV, Goldberg D, Schein PS

DOI 10.1007/bf00175407↗

Design: Randomized Controlled Trial (crossover)

Abstract

Oral delta-9-tetrahydrocannabinol (THC), 15 mg/m2, was compared to prochlorperazine (PCZ), 10 mg. for the control of cancer chemotherapy-related emesis. Thirty-six patients whose vomiting was refractory to standard antiemetic therapy were entered in this randomized comparative cross-over study. THC decreased nausea and vomiting in 23 of 36 (64%) patients compared to 1 of 36 receiving PCZ. THC efficacy was not dependent on the class of antineoplastic-agent inducing the emetic symptoms, age of patients or type of sensorial change experienced. Using the 15 mg/m2 dose, all patients experienced transient sensorial changes, characterized as a pleasant "high" in 19 or a variable state of dysphoria in 17 cases. This study confirms the usefulness of THC in patients whose chemotherapy-induced nausea and vomiting is refractory to other standard antiemetics. While excellent antiemetic control was achieved at the dosage 15 mg/m2, dysphoria was encountered at this dose level and we recommend that an initial dose of 5 mg/m2 which, if necessary, can be carefully increased to achieve maximum antiemetic benefit.

The impediment to action advances action. — Marcus Aurelius