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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 tr

Por: Shimomura · M. · Ishikawa · S. · Miguchi · M. · Shinozaki · K. · Ikeda · S. · Kobayashi · H. · Nakahara · M. · Sumitani · D. · Shimizu · W. · Kohyama · M. · Saito · Y. · Mukai · S. · Hirata · Y. · Kochi · M. · Shimizu · Y. · Takakura · Y. · Yoshimitsu · M. · Kodama · S. · Uegami · S. · Yano
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

Bacterial community associated with the surface and inside of centipede forcipules: Identification and characterization

by Yasutaka Tanaka, Daiki Mizushima, Yoshimitsu Izawa, Tomohiro Matsumura, Chikara Yonekawa, Hirotomo Kato, Takashi Mato

Background

In tropical to subtropical regions, centipede bites may prompt medical attention, with manifestations largely reflecting venom-related discomfort, although infections, including rare fatal necrotizing soft tissue infection (NSTI), have been reported. However, no reports are available on the commensal bacteria on centipede forcipules.

Objectives

This study aimed to investigate bacterial species residing on and in centipede forcipules and their potential role in post-bite infections.

Methods

Nine Scolopendra mutilans, three Scolopendra japonica, and two Bothropolys rugosus were collected from three regions in Japan. The bacterial composition of their forcipules was analyzed using 16S ribosomal ribonucleic acid gene sequencing and microbiome analysis.

Findings

A diverse bacterial community was observed on the centipede forcipules. Among the NSTI-associated genera examined (Escherichia, Staphylococcus, and Streptococcus), only Staphylococcus was identified as a minor population.

Conclusion

This study provides the first evidence that some bacteria found on centipede forcipules have been previously isolated from centipede bite infections. The risk of infection from bacteria on centipede forcipules during a centipede bite appears low. However, the presence of diverse bacterial species emphasizes the importance of thoroughly cleaning centipede bite wounds to prevent secondary infection.

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