alexa The Efficacy and Safety of Sterile Graded Talc in Pleurodesis for Malignant Pleural Effusion: Phase II Study | OMICS International
ISSN: 2167-0870

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Protocol

The Efficacy and Safety of Sterile Graded Talc in Pleurodesis for Malignant Pleural Effusion: Phase II Study

Hideo Saka1*, Masahide Oki1, Chiyoe Kitagawa1, Yoshihito Kogure1, Yuki Kojima1, Akiko M. Saito2, Atsuko Ishida3, Terunao Miyazawa3, Koji Takeda4, Kazuhiko Nakagawa5, Shinji Sasada6 and Shunichi Negoro7

1Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan

2Clinical Research Center, National Hospital Organization, Nagoya Medical Center, Japan

3Department of Respiratory/Infectious Diseases, St. Marianna University School of Medicine Hospital, Japan

4Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan

5Department of Medical Oncology, Kindai University Hospital, Osaka, Japan

6Department of Respiratory Medicine, Saiseikai Central Hospital, Tokyo, Japan

7Department of Medical Oncology, Hyogo Cancer Center, Hyogo, Japan

*Corresponding Author:
Hideo Saka
Department of Respiratory Medicine
National Hospital Organization Nagoya Medical Center, Nagoya, Japan
Tel: +81-52-951-1111
Fax: +81-52-212-7360
E-mail: [email protected]

Received date: July 29, 2016; Accepted date: August 23, 2016; Published date: December 29, 2016

Citation: Saka H, Oki M, Kitagawa C, Kogure Y, Kojima Y, et al. (2016) The Efficacy and Safety of Sterile Graded Talc in Pleurodesis for Malignant Pleural Effusion: Phase II Study. J Clin Trials 6:279. doi:10.4172/2167-0870.1000279

Copyright: © 2016 Saka H, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Objective: Introduction of NPC-05 (sterile graded talc) into Japanese clinical practice is expected to lead to persistent prevention of re-accumulation of MPE and alleviation of concomitant symptoms in patients, including dyspnea and chest pain. We conduct an investigator-initiated trial in Japan to clarify the efficacy and safety of NPC-05 for use as a pleurodesis agent. Methods: This study is a multicenter uncontrolled open-label phase II study. An uncontrolled open-label joint clinical study is conducted in 6 institutes, involving 30 patients with MPE. Conclusion: Sterile graded talc has been described as the most useful pleurodesis drug for treating malignant pleural effusion in many guidelines and meta-analyses; thus, it is used as a standard pleurodesis agent in Western countries. However, its efficacy and safety have not been examined in Japan. This study assessed the efficacy and safety of NC-05, sterile graded talc, in 30 Japanese patients with malignant pleural effusion.

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