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Study register · detail RCT (doppelblind, Placebo-kontrolliert, Dosisfindung Phase II) · Cancer · 1984

Dose ranging evaluation of the antiemetic efficacy and toxicity of intramuscular levonantradol in cancer subjects with chemotherapy-induced emesis.

Stambaugh et al. ·The Journal of Clinical Pharmacology

Clear benefit GRADE Moderate 23 citations

Samplen = 20 Pat.

Duration24 hours

ControlPlacebo

EndpointAntiemetic efficacy

Blindingdoppelblind

DesignRCT (doppelblind, Placebo-kontrolliert, Dosisfindung Phase II)

Cannabinoidthc

Max. dose2.0 mg

Key finding

All levonantradol doses significantly reduced chemotherapy-induced emesis compared to placebo (p<0,01) without a demonstrable dose-response effect.

Summary

n=20 patients with advanced cancer and refractory chemotherapy-induced emesis; synthetic cannabinoid levonantradol 0,5–2,0 mg i.m. vs. placebo; antiemetic activity significant for all doses versus placebo (p<0,01); tolerability acceptable up to 2,0 mg. No efficacy advantage with cisplatin-containing regimens.

PopulationCancer patients with chemotherapy-induced refractory emesis, n=20

InterventionIntramuscular levonantradol (synthetic cannabinoid) in doses of 0,5 / 1,0 / 1,5 / 2,0 mg, prophylactically before chemotherapy, repeated over 12 hours

ControlPlacebo (intramuscular)

OutcomeSignificant antiemetic efficacy of all levonantradol doses vs. placebo (p<0,01); no dose-response relationship demonstrable

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 Clear benefit

Citations / year ★★★★★

Authors

Stambaugh JE, McAdams J, Vreeland F.

DOI 10.1002/j.1552-4604.1984.tb02756.x↗

Design: RCT (doppelblind, Placebo-kontrolliert, Dosisfindung Phase II)

Abstract

A phase II double-blind placebo-controlled, randomized dose-ranging trial was undertaken to determine the antiemetic efficacy and toxicity of the synthetic cannabinoid levonantradol at doses of 0.5, 1.0, 1.5, and 2.0 mg. Intramuscular levonantradol was prophylactically administered in random dosing to 20 subjects with a documented history of refractory emesis due to chemotherapy in advanced cancer. The selected dose was administered prior to the chemotherapy and was serially repeated over 12 hours, and efficacy and toxicity data were evaluated for 24 hours. Significant (P less than 0.01) antiemetic activity over placebo was observed with all doses of levonantradol administered, and a dose-effect response was not observed. Doses up to 2.0 mg were well tolerated, and observed toxicity increased with increased doses and with repeated dosing. Psychomimetic effects were mild and tolerable, and the limiting side effects were somnolence and hypotension.

The impediment to action advances action. — Marcus Aurelius