{
  "abstract": "Background Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN.Methods This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026.Ethics and dissemination This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.Trial registration number jRCTs062240066",
  "authors": [
    {
      "affiliations": [
        "Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan"
      ],
      "name": "Manabu Shimomura"
    },
    {
      "affiliations": [
        "Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan"
      ],
      "name": "Sho Ishikawa"
    },
    {
      "affiliations": [
        "Department of Surgery, Hiroshima Prefectural Hospital, Hiroshima, Japan"
      ],
      "name": "Masashi Miguchi"
    },
    {
      "affiliations": [
        "Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan"
      ],
      "name": "Katsunori Shinozaki"
    },
    {
      "affiliations": [
        "Department of Surgery, Hiroshima Prefectural Hospital, Hiroshima, Japan"
      ],
      "name": "Satoshi Ikeda"
    },
    {
      "affiliations": [
        "Department of Surgery, Hiroshima Memorial Hospital, Hiroshima, Japan"
      ],
      "name": "Hironori Kobayashi"
    },
    {
      "affiliations": [
        "Department of Surgery, Onomichi General Hospital, Onomichi, Japan"
      ],
      "name": "Masahiro Nakahara"
    },
    {
      "affiliations": [
        "Department of Surgery, Kenritsu Futabanosato Byoin, Hiroshima, Japan"
      ],
      "name": "Daisuke Sumitani"
    },
    {
      "affiliations": [
        "Department of Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan"
      ],
      "name": "Wataru Shimizu"
    },
    {
      "affiliations": [
        "Department of Surgery, Hiroshima General Hospital, Hatsukaichi, Japan"
      ],
      "name": "Mohei Kohyama"
    },
    {
      "affiliations": [
        "Department of Surgery, Kure Kyosai Hospital, Kure, Japan"
      ],
      "name": "Yasufumi Saito"
    },
    {
      "affiliations": [
        "Department of Surgery, Chugoku Rosai Hospital, Kure, Japan"
      ],
      "name": "Shoichiroh Mukai"
    },
    {
      "affiliations": [
        "Department of Surgery, Saiseikai Hiroshima Hospital, Hiroshima, Japan"
      ],
      "name": "Yuzo Hirata"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan"
      ],
      "name": "Masatoshi Kochi"
    },
    {
      "affiliations": [
        "Department of Surgery, National Hospital Organization Kure Medical Center, Kure, Japan"
      ],
      "name": "Yosuke Shimizu"
    },
    {
      "affiliations": [
        "Department of Surgery, Chuden Hospital, Hiroshima, Japan"
      ],
      "name": "Yuji Takakura"
    },
    {
      "affiliations": [
        "Department ofSurgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan"
      ],
      "name": "Masanori Yoshimitsu"
    },
    {
      "affiliations": [
        "Department of Surgery, Yoshida General Hospital, Akitakata, Japan"
      ],
      "name": "Shinya Kodama"
    },
    {
      "affiliations": [
        "Department of Surgery, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan"
      ],
      "name": "Shinnosuke Uegami"
    },
    {
      "affiliations": [
        "Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan"
      ],
      "name": "Takuya Yano"
    },
    {
      "affiliations": [
        "Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan"
      ],
      "name": "Hiroshi Okuda"
    },
    {
      "affiliations": [
        "Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan"
      ],
      "name": "Hideki Ohdan"
    },
    {
      "affiliations": [],
      "name": "Hiroshima Surgical study group of Clinical Oncology (HiSCO)"
    }
  ],
  "title": "Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial–the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 trial",
  "uid": "a1fae141-3406-58ed-8808-b205e8ca23ad"
}