Study register · detail
No benefit demonstrated
GRADE
Low
38 citations
Samplen = 110 Pat.
DurationAcute phase
EndpointComplete acute CIV control
Blindingn.a.
DesignMultizentrische retrospektive Übersicht
Cannabinoidthc
Routeoral
Key finding
Acute vomiting control under nabilone was insufficient at approx. 50%, side effects were frequent but of little clinical significance.
Summary
n=110 pediatric cancer patients (median 14 years); nabilone (cannabinoid) + 5-HT3 antagonist for acute CINV prophylaxis; complete acute vomiting control: 50,6% (42/83) with highly emetogenic, 53,8% (14/26) with moderately emetogenic chemotherapy; side effects in 34% (37/110), all CTCAE grade ≤2; sedation 20%, dizziness 10%, euphoria 3,6%; discontinuation due to adverse drug reactions in 10 patients.
P
PopulationPediatric patients (median age 14,0 years, range 1,1–18,0 years) undergoing chemotherapy with acute CINV prophylaxis need, n=110
I
InterventionNabilone (oral) for acute CINV prophylaxis, mostly in combination with a 5-HT3 antagonist (109/110 patients)
O
OutcomeComplete acute vomiting control in 50,6% (42/83) of patients with highly emetogenic and 53,8% (14/26) with moderately emetogenic chemotherapy; adverse events in 34% (all CTCAE grade ≤2)
Confidence in the evidence
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Quality profile
Sample size
★★★★★
Blinding
—
Effect size
No benefit
Citations / year
★★★★★
Authors
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Abstract
<h4>Objectives</h4>To describe the safety and efficacy of nabilone given to pediatric patients to prevent acute chemotherapy-induced nausea and vomiting (CINV).<h4>Methods</h4>A multicenter, retrospective review of pediatric patients who received nabilone for acute CINV prophylaxis between December 1, 2010 and August 1, 2015 was undertaken. One course of nabilone was evaluated per patient. Adverse effects associated with nabilone use were noted. The proportion of patients who experienced complete acute chemotherapy-induced vomiting (CIV) control during the acute phase was determined. The acute phase was defined as starting with the first chemotherapy dose and continuing until 24 h after administration of the last chemotherapy dose of the chemotherapy block.<h4>Results</h4>One hundred ten eligible patients (median age: 14.0 years, range: 1.1-18.0 years; 65 male) were identified. Most (109/110) received nabilone plus a 5-HT3 antagonist for CINV prophylaxis. Adverse effects associated with nabilone were experienced by 34% (37/110) of children. All were of CTCAE Version 4.03 Grade 2 or less. Sedation (20.0%), dizziness (10.0%), and euphoria (3.6%) were the most commonly reported adverse events. Nabilone was discontinued in 10 patients due to an adverse event. The proportions of patients receiving highly or moderately emetogenic chemotherapy who experienced complete acute CIV control were 50.6% (42/83) and 53.8% (14/26), respectively.<h4>Conclusion</h4>Adverse events associated with nabilone were common but of minor clinical significance. Acute CIV control in children receiving nabilone as a part of their antiemetic regimen was poor. Future work should focus on implementation of guideline-consistent CINV prophylaxis and treatment.
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