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Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting

Date

09 Oct 2016

Session

Poster display

Presenters

Carla Rossi

Citation

Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390

Authors

C.S. Rossi1, F.M. Cruz2, A. del Giglio2, C.M. Rodrigues3, S.N. Castro3

Author affiliations

  • 1 Oncology, IBCC Instituto Brasileiro de Controle do Cancer, 03101-005 - Sao Paulo/BR
  • 2 Oncology, Faculdade de Medicina do ABC, Santo André/BR
  • 3 Oncology, IBCC Instituto Brasileiro de Controle do Cancer, Sao Paulo/BR
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Resources

Abstract 3350

Background

Previous studies showed that anticonvulsants might improve the prevention of chemotherapy-induced nausea and vomiting (CINV). Pregabalin is a structural derivative of the inhibitory neurotransmitter γ-aminobutyric acid. It binds potently to the calcium channels, resulting in a reduction in the release of several neurotransmitters including glutamate, noradrenaline, serotonin, dopamine, and substance P. Some of these transmitters are involved on the physiophathology of nausea and vomiting. To our knowledge, the antiemetic role of pregabalin hasn't been investigated yet.

Methods

We performed a phase II randomized, double-blind, placebo-controlled trial to investigate if pregabalin could improve the complete control of nausea and vomiting (primary end point). We enrolled eighty two chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chdmotherapy. All patients received IV ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3. Patients were randomly assigned to take pregabalin 75 mg or placebo, bd, from the night before chemotherapy to day 5. All patients received a diary to record the moment of failure, considered in this study as any episode of emesis, moderate or severe nausea or use of rescue medication. We used chi2 test to evaluate the difference of proportions between groups.

Results

The overall complete response were 53.7 vs.48.8% respectively in the pregabalin and control group (p = 0.65). There was also no significant difference during the acute phase(first 24h) or delayed phase (24-120h): 80.5% vs 82.9% (p = 0.77), 53.7 vs 51.2% (p = 0.82).

Conclusions

There is no role for pregabalin in the prevention of chemotherapy induced nausea and vomiting.

Clinical trial identification

CAAE 49488915.1.0000.0072 Date 08/20/2015

Legal entity responsible for the study

IBCC Instituto Brasileiro de Controle do Cancer

Funding

IBCC Instituto Brasileiro de Controle do Cancer

Disclosure

All authors have declared no conflicts of interest.

Resources from the same session

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