Nausea
Study register · detail RCT (aktiv-kontrolliert, Crossover) · Nausea · 1988

A randomized trial of oral nabilone and prochlorperazine compared to intravenous metoclopramide and dexamethasone in the treatment of nausea and vomiting induced by chemotherapy regimens containing cisplatin or cisplatin analogues.

Mixed GRADE Moderate 59 citations
Samplen = 80 Pat.
ControlI.v. metoclopramide + i.v. dexamethasone 20…
EndpointComplete control of…
Blindingoffen
DesignRCT (aktiv-kontrolliert, Crossover)
Cannabinoidthc
Max. dose8.0 mg
Routeoral
Key finding

Metoclopramide/dexamethasone was objectively superior, however carboplatin patients preferred nabilone/prochlorperazine due to better tolerability.

Summary

n=80 chemotherapy patients (cisplatin/cisplatin analogues), nabilone 2 mg + prochlorperazine 5 mg orally vs. metoclopramide i.v. + dexamethasone; complete control of nausea and vomiting: 19% (nabilone arm) vs. 32% (metoclopramide arm), overall emesis p=0.02 in favour of metoclopramide. Carboplatin subgroup: patient preference for nabilone (16 vs. 5, p=0.013). Nabilone was better tolerated and preferred in carboplatin regimens.

P
PopulationAdults undergoing cisplatin- or cisplatin analogue-containing chemotherapy (first cycle), n=80
I
InterventionNabilone 2 mg orally + prochlorperazine 5 mg orally every 12 h, 4 doses
C
ControlI.v. metoclopramide (2 mg/kg loading + 3 mg/kg infusion over 8 h) + i.v. dexamethasone 20 mg
O
OutcomeComplete control of nausea/vomiting: 32% (metoclopramide/dexamethasone) vs. 19% (nabilone/prochlorperazine); emesis scale significantly in favour of metoclopramide/dexamethasone (p=0,02); patient preference, however, not significantly different (31 vs. 26; p n.s.), in carboplatin patients preference for nabilone/prochlorperazine (16 vs. 5; p=0,013)
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 Open-label
Effect size Mixed
Citations / year
Authors
Cunningham D, Bradley CJ, Forrest GJ, Hutcheon AW, Adams L, Sneddon M, Harding M, Kerr DJ, Soukop M, Kaye SB.
DOI 10.1016/0277-5379(88)90300-8
Design: RCT (aktiv-kontrolliert, Crossover)
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Abstract
Eighty patients receiving their first course of chemotherapy with regimens containing cisplatin or cisplatin analogues entered this open crossover study comparing nabilone 2 mg and prochlorperazine 5 mg given orally every 12 h for four doses against metoclopramide 2 mg/kg loading dose intravenously (i.v.), then 3 mg/kg as an (i.v.) infusion over 8 h and dexamethasone 20 mg (i.v.) over 3-5 min at the time of chemotherapy. There was complete control of nausea and vomiting in 24 patients (32%) given metoclopramide and dexamethasone compared to 14 patients (19%) given nabilone and prochlorperazine. For the 70 patients who completed the crossover assessment of emesis on a linear analogue scale significantly favoured metoclopramide and dexamethasone (P = 0.02). However, there was no overall patient preference for the metoclopramide and dexamethasone combination (nabilone and prochlorperazine 31 vs. metoclopramide and dexamethasone 26; 13 no preference), because a significant proportion of the patients receiving the cisplatin analogue carboplatin preferred nabilone and prochlorperazine (16 vs. 5; 1 no preference; P = 0.013). For patients receiving cisplatin chemotherapy metoclopramide and dexamethasone remains the antiemetic of choice but for regimens containing carboplatin, nabilone and prochlorperazine is better tolerated and preferred by the patients.

The impediment to action advances action. — Marcus Aurelius