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BioMed Research International
Volume 2015 (2015), Article ID 523601, 7 pages
http://dx.doi.org/10.1155/2015/523601
Clinical Study

A Randomized, Double-Blind Pilot Study of Dose Comparison of Ramosetron to Prevent Chemotherapy-Induced Nausea and Vomiting

1Department of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea
2Division of Clinical Pharmacology, Chonnam National University Hospital, Gwangju 519-763, Republic of Korea
3Department of Pharmacology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea
4Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea

Received 19 December 2014; Revised 21 January 2015; Accepted 3 February 2015

Academic Editor: Bernardo L. Rapoport

Copyright © 2015 Ka-Rham Kim et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose. This study was conducted to determine the optimal dose titration of ramosetron to prevent the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). Methods. Patients treated with folic acid, 5-fluorouracil, and oxaliplatin were randomized into three groups (0.3 mg, 0.45 mg, and 0.6 mg ramosetron before chemotherapy). The pharmacokinetics and pharmacodynamics using RINVR were evaluated. Results. Seventeen, 15, and 18 patients received ramosetron at doses of 0.3 mg, 0.45 mg, and 0.6 mg, respectively. (h), (ng/mL), and (ng·h/mL) were associated with dose escalation significantly, showing a reverse correlation with the RINVR during chemotherapy. Acute CINV was observed in four patients (22.2%), two patients (14.3%), and one (5.6%) patient and a delayed CINV on day 7 was found in eight (47%), three (21.4%), and five (27.8%) patients in each group. The complete response rate was increased with dose escalation (35.3%, 50.0%, and 72.2% in each group) and also showed the tendency for decreasing moderate-to-severe CINV. Conclusions. This study shows a trend regarding the dose-response relationship for ramosetron to prevent CINV, including delayed emesis. It suggested that dose escalation should be considered in patients with CINV in a subsequent cycle of chemotherapy, and an individual approach using RINVR could be useful to monitor CINV.