A randomized controlled trial using surgical gloves to prevent chemotherapy-induced peripheral neuropathy by paclitaxel in breast cancer patients (AIUR trial)

• Published in: BMC cancer 2023-06, Vol.23 (1), p.570-570, Article 570
• Main Authors: Kang, Young-Joon, Yoon, Chang Ik, Yang, Yun-Jung, Baek, Jong Min, Kim, Yong-Seok, Jeon, Ye Won, Rhu, Jiyoung, Yi, Jae Pak, Kim, Dooreh, Oh, Se Jeong
• Format: Article
• Language: English
• Subjects: Adverse effects, peripheral nervous system disease; Antimitotic agents; Antineoplastic agents; Antineoplastic Agents - adverse effects; Breast cancer; Breast neoplasm, antineoplastic agents; Breast Neoplasms - drug therapy; Breast Neoplasms - surgery; Cancer; Cancer patients; Care and treatment; Chemically induced; Chemotherapy; Clinical trials; Complications and side effects; Cost benefit analysis; Diagnosis; Female; Gloves, Surgical; Health aspects; Humans; Methods; Paclitaxel; Patient compliance; Patient outcomes; Peripheral Nervous System Diseases - chemically induced; Peripheral Nervous System Diseases - drug therapy; Peripheral Nervous System Diseases - prevention & control; Prevention; Quality of Life; Study Protocol; Taxoids - adverse effects
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-023-11079-8

Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of taxane treatment and can significantly affect patient quality of life. Currently, there are no effective treatments to alleviate symptoms of CIPN; thus, starting with prevention steps in high-risk patients is considered advantageous. However, for these prevention steps to be applicable to all patients, their side effects or accompanying discomforts should be minimal, and the intervention cost-effective. Compression therapy can be considered a prevention intervention, and using surgical gloves is feasible and cost-effective (approximately $0.6 per pair). Although previous studies on compression therapy using surgical gloves have reported decreased incidence of PN, these studies were non-randomized, limited to nab-paclitaxel treatment, and involved the use of small gloves, which may have caused discomfort. Therefore, this study aimed to assess the preventive effects of compression therapy using normal-sized surgical gloves on CIPN in patients treated with paclitaxel. This clinical trial is designed to evaluate the preventive effects of compression therapy using surgical gloves on CIPN in women with stage II-III breast cancer who received paclitaxel chemotherapy for at least 12 weeks. This multicenter, randomized-controlled, open-label study will be conducted in six academic hospitals. Patients with medication or a medical history related to neuropathy or hand disease will be excluded. The primary outcome will be the preventive effect of compression therapy using surgical gloves, measured based on changes in the neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane questionnaire. Furthermore, we will assess the National Cancer Institute's Common Terminology Criteria for Adverse Events grade of CIPN after 6 months. Notably, the estimated sample size, based on a p-value