{
  "abstract": "Introduction Opioid-induced nausea and vomiting (OINV) in patients with cancer imposes a substantial clinical burden and may compromise adherence to opioid therapy. Naldemedine, a peripheral μ-opioid receptor antagonist, is currently approved for the treatment of opioid-induced constipation. Recent evidence suggests similar benefits for the treatment of OINV. This study aims to evaluate the preventive effect of naldemedine on OINV in patients with cancer pain initiating opioid analgesics.Methods and analysis This multicentre, double-blind, randomised, placebo-controlled, parallel-group comparison trial will be conducted across 20 hospitals and clinics in Japan. An estimated 120 patients with cancer scheduled to initiate opioid analgesic therapy will be recruited and randomly assigned (1:1) to receive either naldemedine or placebo on day 1 (visit 1). From days 1 to 7, patients will receive blinded study medication concurrently with opioid analgesics and will be followed for 8 days. The primary endpoint will be the proportion of patients achieving a complete response (CR) on day 5, defined as no vomiting and no use of rescue antiemetics for up to 120 hours after initiation of opioid analgesics. Key secondary endpoints will include the proportion of patients achieving CR on days 1, 2, 3 and 7; changes in Numerical Rating Scale scores from baseline; duration of nausea; proportion of patients who experience vomiting; proportion of patients using rescue antiemetics and frequency of rescue antiemetic use. Additionally, the incidence of adverse events and serious adverse events will be recorded throughout the observation period.Ethics and dissemination This study has been reviewed and approved by the Hattori Clinic Certified Review Board (approval number: CRB3180027). Written informed consent will be obtained from all participating patients before study commencement. The results of the study will be presented at academic conferences in Japan or overseas and submitted for publication in a peer-reviewed journal.Trial registration number NCT07038551 and jRCTs031250128.",
  "authors": [
    {
      "affiliations": [
        "Department of Palliative Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan",
        "Department of Gastroenterology, International University Health and Welfare School of Medicine, Chiba, Japan"
      ],
      "name": "Yo Ishihara"
    },
    {
      "affiliations": [
        "Department of Nursing, International University of Health and Welfare Narita Hospital, Chiba, Japan"
      ],
      "name": "Mayumi Ohira"
    },
    {
      "affiliations": [
        "Department of Pharmacy, International University of Health and Welfare Narita Hospital, Chiba, Japan"
      ],
      "name": "Mitsuki Hokabe"
    },
    {
      "affiliations": [
        "Department of Pharmacy, International University of Health and Welfare Narita Hospital, Chiba, Japan"
      ],
      "name": "Sadaaki Yoshino"
    },
    {
      "affiliations": [
        "Department of Pharmacy, International University of Health and Welfare Narita Hospital, Chiba, Japan"
      ],
      "name": "Kohei Iwashita"
    },
    {
      "affiliations": [
        "Department of Palliative Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan",
        "Department of Gastroenterology, International University Health and Welfare School of Medicine, Chiba, Japan"
      ],
      "name": "Kota Takahashi"
    },
    {
      "affiliations": [
        "Department of Palliative Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan",
        "Department of Gastroenterology, International University Health and Welfare School of Medicine, Chiba, Japan"
      ],
      "name": "Naoki Tomita"
    },
    {
      "affiliations": [
        "Department of Palliative Medicine, Kyoto University Hospital, Kyoto, Japan"
      ],
      "name": "Yu Uneno"
    },
    {
      "affiliations": [
        "Department of Medical Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Shigeki Kataoka"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Kanagawa Dental University Yokohama Clinic, Kanagawa, Japan"
      ],
      "name": "Takeo Kurihashi"
    },
    {
      "affiliations": [
        "Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Eriko Satomi"
    },
    {
      "affiliations": [
        "Department of Palliative and Supportive Care, Institute of Medicine, University of Tsukuba, Ibaraki, Japan"
      ],
      "name": "Jun Hamano"
    },
    {
      "affiliations": [
        "Department of Palliative and Supportive Care, Institute of Medicine, University of Tsukuba, Ibaraki, Japan"
      ],
      "name": "Takahiro Higashibata"
    },
    {
      "affiliations": [
        "Department of Palliative and Supportive Care, University of Tsukuba Hospital, Ibaraki, Japan"
      ],
      "name": "Kazuhiro Kosugi"
    },
    {
      "affiliations": [
        "Department of Palliative Medicine, St. Marianna University School of Medicine, Kanagawa, Japan"
      ],
      "name": "Mami Hirakawa"
    },
    {
      "affiliations": [
        "Medical Oncology and Palliative Medicine Department, Toyama University Hospital, Toyama, Japan"
      ],
      "name": "Shinya Kajiura"
    },
    {
      "affiliations": [
        "Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan"
      ],
      "name": "Suguru Ogihara"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Showa University Koto Toyosu Hospital, Tokyo, Japan"
      ],
      "name": "Masaki Kida"
    },
    {
      "affiliations": [
        "Department of Palliative and Supportive Care, Seirei Mikatahara General Hospital, Shizuoka, Japan"
      ],
      "name": "Tatsuya Morita"
    },
    {
      "affiliations": [
        "Data Science Department, Shionogi & Co., Ltd, Osaka, Japan"
      ],
      "name": "Yuichi Koretaka"
    },
    {
      "affiliations": [
        "Drug Development and Regulatory Science Division, Shionogi & Co., Ltd, Osaka, Japan"
      ],
      "name": "Takuhiro Sonoyama"
    },
    {
      "affiliations": [
        "Department of Biostatistics, JORTC Data Centre, Tokyo, Japan"
      ],
      "name": "Shunsuke Oyamada"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Shizuoka, Japan"
      ],
      "name": "Atsushi Nakajima"
    },
    {
      "affiliations": [
        "Department of Palliative Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan",
        "Department of Gastroenterology, International University Health and Welfare School of Medicine, Chiba, Japan",
        "Department of Internal Medicine, Kanagawa Dental University Yokohama Clinic, Kanagawa, Japan"
      ],
      "name": "Takaomi Kessoku"
    }
  ],
  "title": "Multicentre, double-blind, randomised, placebo-controlled study on the prophylactic use of naldemedine for opioid-induced nausea and vomiting in patients with cancer (POSEIDON study): a protocol paper",
  "uid": "af4cfe46-bb8c-5682-b803-e42b2c157f2b"
}