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☐ ☆ ✇ BMJ Open

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 — Febrero 16th 2026 at 14:29
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

☐ ☆ ✇ BMJ Open

Association between rurality and mortality from major diseases in Japan: an ecological study

Por: Kaneko · M. · Ikeda · T. — Enero 27th 2026 at 01:06
Objectives

This study aimed to examine rural–urban disparities in healthcare outcomes in Japan using the Rurality Index for Japan (RIJ). It evaluated the association between rurality and mortality from five major diseases prioritised by the Japanese government, accounting for socioeconomic and demographic factors.

Design

An ecological study using publicly available data at municipal and administrative district levels.

Setting

All municipalities and administrative districts within government-designated cities in Japan.

Participants

A total of 1897 municipalities and administrative districts were analysed, excluding areas with zero population. The total number of the population was approximately 126 million.

Exposure

Rurality was measured using RIJ.

Primary outcome measures

Standardised mortality ratios (SMRs) were used for acute myocardial infarction (AMI), cerebrovascular diseases (stroke and haemorrhage), cancer and suicide. The standardised claim ratio (SCR) for diabetes outpatient care served as a proxy measure due to the unavailability of mortality data.

Results

Greater rurality, as quantified by RIJ, was associated with higher SMRs for cerebrovascular diseases and male suicide. A dose-response relationship was observed among SMRs for cerebrovascular disease and male suicide, whereas AMI mortality was higher in rural areas but lacked a strict dose-dependent trend. No significant association was found between rurality and cancer mortality or diabetes in outpatient SCR. Additionally, RIJ was positively correlated with the proportion of older adults (Spearman’s =0.67) and the Arial Deprivation Index (=0.55).

Conclusion

These findings highlight the need for targeted rural health policies that improve access to emergency care and mental health services.

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