←Cancer
Study register · detail RCT (doppelblind, Crossover) · Cancer · 1984

Double-blind multiple-dose crossover study of the antiemetic effect of intramuscular levonantradol compared to prochlorperazine.

Sheidler et al. ·The Journal of Clinical Pharmacology
No benefit demonstrated GRADE Moderate 20 citations
Samplen = 16 Pat.
Duration4 doses per course
ControlProchlorperazine 10 mg i.m., same dosing…
EndpointAntiemetic efficacy
Blindingdoppelblind
DesignRCT (doppelblind, Crossover)
Cannabinoidthc
Max. dose4.0 mg
Routeinhalativ
Key finding

Levonantradol was not more effective as an antiemetic than prochlorperazine, but showed a higher rate of side effects.

Summary

RCT crossover (n=16 cancer patients undergoing chemotherapy); synthetic cannabinoid levonantradol 1 mg i.m. vs. prochlorperazine 10 mg i.m. for antiemesis; no statistically significant difference in antiemetic response. Levonantradol showed more frequent adverse effects than prochlorperazine. Negative study; historical finding on cannabinoid antiemesis in oncology (n<60).

P
PopulationCancer patients undergoing chemotherapy, n=20 (16 crossover completed)
I
InterventionLevonantradol 1 mg i.m. (synthetic cannabinoid), 4 doses: 2 h before and 2/6/10 h after chemotherapy
C
ControlProchlorperazine 10 mg i.m., same dosing schedule
O
OutcomeNo statistically significant difference in antiemetic efficacy between levonantradol and prochlorperazine; higher rate of side effects with levonantradol
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 No benefit
Citations / year ★★★★★
Authors
Sheidler VR, Ettinger DS, Diasio RB, Enterline JP, Brown MD.
DOI 10.1002/j.1552-4604.1984.tb01824.x↗
Design: RCT (doppelblind, Crossover)
Share
Abstract
Twenty cancer patients who received chemotherapy were entered into a double-blind crossover design antiemetic study comparing 1 mg levonantradol, an investigational synthetic cannabinoid, to 10 mg prochlorperazine. Sixteen patients completed the crossover. For each antiemetic course, four doses of each study medication were given intramuscularly 2 hours before chemotherapy and then 2, 6, and 10 hours after chemotherapy administration. There were no statistical differences in patients' responses to levonantradol and prochlorperazine. The frequency of side effects was greater with levonantradol than with prochlorperazine. The most common side effect of levonantradol were somnolence, dry mouth, dizziness, tachycardia, postural hypotension, and blurred vision, while those for prochlorperazine were somnolence, dry mouth, and tachycardia.
Indication
Further studies on Cancer
All studies →
S Hauser et al. · 2023 · The Cochrane database of systematic reviews
53 citations
Cannabis-based medicines and medical cannabis for adults with cancer pain.
No benefit demonstrated Meta-Analyse

Cochrane SR, k=14 RCTs (n=1.823), Cannabis-basierte Medikamente vs. Placebo bei moderaten bis schweren Krebsschmerzen trotz Opioid-Therapie. Moderate Evidenz: Nabiximols/THC keine klinisch relevante Wirksamkeit; PGIC-Verbesserung RD=0,06 (95%-KI 0,01–0,12; NNTB=16); Schmerzintensität SMD=-0,19 (95%-KI -0,40 bis 0,02). Niedrige Evidenz: CBD kein Zusatznutzen gegenüber Palliativversorgung allein (1 Studie, n=144). Fazit: Moderate Evidenz für Unwirksamkeit oraler/oromukosaler Cannabinoide bei opioid-refraktären Krebsschmerzen.

10.1002/14651858.cd014915.pub2 View study →
S Herman et al. · 1979 · The New England Journal of Medicine
216 citations
Superiority of nabilone over prochlorperazine as an antiemetic in patients receiving cancer chemotherapy.
Clear benefit Randomized Controlled Trial (double-blind crossover)

n=113 Krebspatienten unter Chemotherapie (Doppelblind-Crossover-RCT, NEJM 1979); Ansprechrate Nabilon 80% vs. Prochlorperazin 32% (p&lt;0,001); Übelkeit (p&lt;0,01) und Erbrechen (p&lt;0,001) jeweils signifikant seltener unter Nabilon; Patienten bevorzugten Nabilon zur Fortführung (p&lt;0,001).

10.1056/nejm197906073002302 View study →
S Whiting et al. · 2015 · JAMA
2103 citations
Cannabinoids for Medical Use
Mixed

Umfassende SR über 79 RCTs (n=6.462) zu medizinischem Cannabis; moderate Evidenz für Chemotherapie-induzierte Übelkeit/Erbrechen (CINV), schwache Evidenz für Appetit-Stimulation bei HIV/Krebs-Kachexie; Nabilon/Dronabinol überlegen vs. Placebo (OR=3.82 für CINV-Kontrolle, 95%-KI 1.55–9.42).

10.1001/jama.2015.6358 View study →

The impediment to action advances action. — Marcus Aurelius