Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Department of Pharmacy, IMSUT Hospital, Institute of Medical Science, University of Tokyo, Tokyo, Japan
Research Article
Study Protocol for a Prospective Observational Study to Evaluate the Efficacy of Fosnetupitant for Long-Delayed Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Platinum-Based Chemotherapy (LODEC-N)
Author(s): Yohei Iimura*, Hirotoshi Iihara, Takeshi Aoyama, Masaaki Ishibashi, Chieko Sasuga, Naoki Furukawa, Eri Anzai, Yuki Ijichi, Sayuri Takahashi, Mariko Tabata, Fusako Niimi, Jun Kaneko, Kazuyoshi Izukuri, Keisuke Baba, Narikazu Boku and Seiichiro Kuroda
Objective: The efficacy of Fosnetupitant (FosNTP) in combination with palonosetron and dexamethasone for
preventing highly emetogenic Chemotherapy Induced Nausea and Vomiting (CINV) was demonstrated in a phase
III study (CONSOLE study). Although the exploratory analysis of the CONSOLE study suggested the effectiveness
of triplet antiemetic therapy, including FosNTP, in the extended overall phase (0 h–168 h), its efficacy in the longdelayed
phase (>168 h) has not been evaluated. Additionally, the efficacy of FosNTPs in moderately emetogenic
chemotherapy is yet to be elucidated. Therefore, this study aims to prospectively assess the efficacy of FosNTP for
CINV in the long-delayed phase (>168 h) in patients receiving platinum-based chemotherapy (cisplatin, carboplatin,
and oxaliplatin).
Methods: This is a single-c.. View More»
DOI:
1 0.35248/2167-0870.23.13.532