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Clinical Trial
. 2005 Oct;6(10):765-72.
doi: 10.1016/S1470-2045(05)70325-9. Epub 2005 Sep 13.

5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial

Jane T Hickok  1 , Joseph A Roscoe, Gary R Morrow, Christopher W Bole, Hongwei Zhao, Karen L Hoelzer, Shaker R Dakhil, Timothy Moore, Tom R Fitch
Affiliations
Clinical Trial

5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial

Jane T Hickok et al. Lancet Oncol. 2005 Oct.

Abstract

Background: Despite widespread use of short-acting antagonists for the 5-hydroxytryptamine (5-HT) receptor, about 50% of patients given moderately emetogenic chemotherapy have delayed nausea. We aimed to assess whether a 5-HT-receptor antagonist was more effective than was prochlorperazine for control of delayed nausea and delayed vomiting caused by doxorubicin.

Methods: 691 patients who previously had not had chemotherapy and who were scheduled to receive doxorubicin were given a short-acting 5-HT-receptor antagonist and dexamethasone before doxorubicin (day 1), and were randomly assigned to one of three regimens for days 2 and 3: 10 mg prochlorperazine taken orally every 8 h; any first-generation 5-HT-receptor antagonist (except palonosetron) taken as standard dose intravenously or orally; or 10 mg prochlorperazine taken as needed. Nausea and vomiting were assessed by use of a home record. The primary endpoint was mean severity of delayed nausea. The secondary endpoint was quality of life. Analyses were done by intention to treat.

Findings: 519 (77%) of the 671 evaluable patients had delayed nausea, with a mean severity of 3.33 (95% CI 3.22-3.44). 161 (71%) of 226 patients assigned prochlorperazine every 8 h reported delayed nausea (mean severity 3.37 [3.16-3.58]), as did 179 (79%) of 226 patients assigned 5-HT-receptor antagonists (3.29 [3.09-3.48]) and 179 (82%) of 219 patients assigned prochlorperazine as needed (3.33 [3.15-3.50]); groups did not differ in mean severity (p=0.853, one-way ANOVA). Patients allocated prochlorperazine every 8 h had less delayed nausea than did those allocated 5-HT-receptor antagonists (p=0.05, t test) and those allocated prochlorperazine as needed (p=0.009, t test).

Interpretation: Short-acting 5-HT-receptor antagonists are no better than is prochlorperazine in control of delayed nausea caused by doxorubicin. Although fewer patients taking prochlorperazine report delayed nausea, the proportion was unacceptably high.

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Figures

Figure 1
Figure 1. Study scheme
Day 1=day of doxorubicin treatment.
Figure 2
Figure 2
Trial profile
Figure 3
Figure 3. Severity of acute and delayed nausea in patients who reported nausea
(A) Mean severity. (B) Maximum severity. Vertical bars are SE.
Figure 4
Figure 4. Proportion of patients with acute and delayed nausea
Vertical bars are upper limit of the 95% CI.
Figure 5
Figure 5. Proportion of patients with acute and delayed vomiting
Vertical bars are upper limit of the 95% CI.
See this image and copyright information in PMC

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