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Clinical Trial
. 2014 Nov 15;120(22):3575-83.
doi: 10.1002/cncr.28892. Epub 2014 Jul 9.

Phase III double-blind, placebo-controlled study of gabapentin for the prevention of delayed chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, NCCTG N08C3 (Alliance)

Debra L Barton  1 , Gita Thanarajasingam, Jeff A Sloan, Brent Diekmann, Jyotsna Fuloria, Lisa A Kottschade, Alan P Lyss, Anthony J Jaslowski, Miroslaw A Mazurczak, Scott C Blair, Shelby Terstriep, Charles L Loprinzi
Affiliations
Clinical Trial

Phase III double-blind, placebo-controlled study of gabapentin for the prevention of delayed chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, NCCTG N08C3 (Alliance)

Debra L Barton et al. Cancer. .

Abstract

Background: Despite targeted antiemetics, data support an unmet need related to the management of delayed nausea and vomiting (NV). Promising pilot data informed this phase III trial evaluating gabapentin for delayed NV from highly emetogenic chemotherapy (HEC).

Methods: Participants were randomized to receive prophylactic treatment with 20 mg of dexamethasone and a 5HT3 receptor antagonist (RA) on the day of chemotherapy, followed by gabapentin 300 mg twice a day and dexamethasone (dex) or placebo and dex after HEC. Gabapentin/placebo was started the day of chemotherapy and continued through day 5 for the first chemotherapy cycle, whereas dex was titrated down on days 2-4. The primary end point was complete response (CR), defined as no emesis and no use of rescue medications on days 2-6, using an NV diary. The percentages of those in each group with a CR were compared by Fisher's exact test.

Results: Four hundred thirty patients were enrolled in this study. Forty-seven percent of patients in the gabapentin arm and 41% in the placebo arm had a CR (P = .23). Mean number of emesis episodes was <0.5 daily, and mean nausea severity was < 2 (mild). In both arms, patient satisfaction with NV control was greater than 8 (with 10 being perfectly satisfied). There were no significant differences in unwanted side effects.

Conclusions: In this study, gabapentin did not significantly improve delayed NV. Patients were satisfied with the control of their nausea and vomiting irrespective of arm. The use of a 5HT3 RA and dexamethasone provided good control of nausea and vomiting for most patients.

Keywords: antiemetic therapy; delayed nausea; delayed vomiting; gabapentin; randomized controlled trial.

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Conflict of interest statement

CONFLICT OF INTEREST DISCLOSURES

Debra L. Barton reports grants from the National Cancer Institute. Jyotsna Fuloria reports grants from the National Cancer Institute, Lisa A. Kottschade reports being on the nurse advisory board of Genentech.

Figures

Figure 1
Figure 1
CONSORT diagram.
Figure 2
Figure 2
Percentage of patients in gabapentin and placebo arms who had a complete response on the indicated day of study. P values obtained via independent t tests for each day.
Figure 3
Figure 3
Mean severity of nausea on the indicated day of study in both the gabapentin and placebo arms. P values obtained via independent t tests for each.
See this image and copyright information in PMC

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