The use of antagonists of the NK1 and/or 5-HT3 receptor is recommended for the patients receiving high emetogenic chemotherapy (HEC) in order to prevent chemotherapy-induced nausea and vomiting (CINV). Although we widely use them for the patients receiving moderately emetogenic chemotherapy (MEC), supporting evidence is insufficient. We therefore planned to measure the blood concentration of 5-HIAA and substance P in patients receiving MEC, and investigate the relation between their levels and CINV.
This is a multicenter exploratory observational research in Japanese patients receiving chemotherapy for gastrointestinal cancer. The key eligibility criteria are as follows: 1) Diagnosed gastrointestinal cancer; 2) Planned to receive high dose cisplatin (for five patients in cohort 1, for validation of measurement), oxaliplatin or irinotecan (for 45 patients in cohort 2); 3) 20 years of age or older; 4) ECOG PS of 0, 1 or 2; 5) Keeping adequate major organ function. By sampling the patients' blood before and 4, 24, 48, 72 and 96 hours after HEC/MEC administration, we measure the changes in blood concentration of substance P and 5-HIAA after chemotherapy, and survey the relevance of blood concentrations of substance P and 5-HIAA and CINV measured by visual analogue scale. This trial is recruiting the patients from 3 institutes from February 2016 to October 2017, and registered as UMIN000021072.
Clinical trial identification
The trial information of this study was registered as UMIN000021072 and released 18th February 2016.
Legal entity responsible for the study
Hokkaido University Hospital
Ono Pharmaceutical Co., Ltd.
Y. Komatsu: Yoshito Komatsu received honoraria from Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co. Ltd., Yakult Pharmaceutical Industry Co. Ltd., Daiichi–Sankyo Ltd. and Bristol–Myers Squibb. M. Nakamura: Takeda, Chugai Pharma, Bayer Yakuhin, Yakult Honsha, Taiho Pharmaceutical, Lilly Japan, and Kirin Pharmaceuticals. N. Sakamoto: Bristol Myers Squibb and Gilead sciences. All other authors have declared no conflicts of interest.