Journal of Clinical Trials
Open Access

Abstract

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

Hideo Saka, Masahide Oki, Chiyoe Kitagawa, Yoshihito Kogure, Yuki Kojima, Akiko Saito, Atsuko Ishida, Terunao Miyazawa, Koji Takeda, Kazuhiko Nakagawa, Shinji Sasada and Shunichi Negoro

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.