Shigeru Tsuyuki1, Kazuhiko Yamagami2, Hiroshi Yoshibayashi3, Tomoharu Sugie4, Yutaka Mizuno5, Satoru Tanaka6, Hironori Kato7, Toshitaka Okuno8, Nobuko Ogura9, Hiroyasu Yamashiro10, Haruko Takuwa11, Yuichiro Kikawa12, Takashi Hashimoto13, Tatsushi Kato14, Sachiko Takahara15, Toshiro Katayama16, Akira Yamauchi17, Takashi Inamoto18. 1. Department of Breast Surgery, Osaka Red Cross Hospital, 5-30 Fudegasaki-cho, Tennoji-ku, Osaka-city, Osaka, 543-8555, Japan. Electronic address: tyksgr@osaka-med.jrc.or.jp. 2. Department of Breast Surgery, Shinko Hospital, 1-4-47 Wakinohama-cho, Chuo-ku, Kobe-city, Hyogo, 651-0072, Japan. Electronic address: kazu.yama.-0825@shinkohp.or.jp. 3. Department of Breast Surgery, Japanese Red Cross Society Wakayama Medical Center, 4-20, Komatsubara, Wakayama-city, Wakayama, 640-8558, Japan. Electronic address: hiro0221@kuhp.kyoto-u.ac.jp. 4. Breast Surgery, Kansai Medical University Hospital, 2-3-1 Shin-machi, Hirakata-City, Osaka, 573-1191, Japan. Electronic address: sugiet@hirakata.kmu.ac.jp. 5. Department of Breast Surgery, Yokkaichi Municipal Hospital, 2-Chome 2-37, Shibata, Yokkaichi-city, Mie, 510-8567, Japan. Electronic address: mizunoy729@yokkaichihp01.jp. 6. Department of Breast Surgery, National Hospital Organization OsakaMinami Medical Center, 2-1 Kidohigashi-cho, Kawachinagano-City, Osaka, 586-8521, Japan. Electronic address: sur112@osaka-med.ac.jp. 7. Department of Breast Surgery, Kobe City Medical Center Central Hospital, 2-1-1, Minatojima Minamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan. Electronic address: h-kato@kcho.jp. 8. Department of Breast Surgery, Kobe City Nishi-Kobe Medical Center, 5-7-1, Kojidai, Nishi-ku, Kobe, Hyogo, 651-2273, Japan. Electronic address: toshitaka_okuno@kcho.jp. 9. Department of Breast Surgery, Kansai Electric Power Hospital, 2-1-7 Fukushima, Fukushima-ku, Osaka-city, Osaka, 553-0003, Japan. Electronic address: ogura.nobuko@e2.kepco.co.jp. 10. Department of Breast Surgery, Tenri Hospital, 300 Mishima-cho, Tenri-city, Nara, 632-8552, Japan. Electronic address: yamashiro.bcs@gmail.com. 11. Department of Breast Surgery, Shiga General Hospital, 4-30 Moriyama 5-chome, Moriyama-city, Shiga, 524-8524, Japan. Electronic address: st24057@yahoo.co.jp. 12. Department of Breast Surgery, Kobe Minimally Invasive Cancer Center, 8-5-1, Minatojima Nakamachi, Chuo-ku, Kobe-city, Hyogo, 650-0046, Japan. Electronic address: u-1ro@kcho.jp. 13. Hashimoto Clinic, 1-7-2, Sumimoto Honnmati, Nada-ku, Kobe-city, Hyogo, 658-0051, Japan. Electronic address: thclinic@ga2.so-net.ne.jp. 14. Department of Surgery, Yamato Takada Municipal Hospital, 1-1 Isonokita-cho, Yamatotakada-city, Nara, 635-8501, Japan. Electronic address: JAB01004@nifty.ne.jp. 15. Department of Breast Surgery, Tazuke Kofukai Medical Research Institute, Kitano Hospital, 2-4-20, Ohgimachi, Kita-ku, Osaka-city, Osaka, 530-8480, Japan. Electronic address: s-takahara@kitano-hp.or.jp. 16. Department of Medical Engineering, Faculty of Health Sciences, Morinomiya University of Medical Science, 1-26-16 Nankokita, Suminoe-ku, Osaka-city, Osaka, 559-8611, Japan. Electronic address: toshiro_katayama@morinomiya-u.ac.jp. 17. Department of Breast Surgery, Nara Prefecture General Medical Center, 897-5 Shichijo-nishimachi 2-chome, Nara-city, Nara, 630-8581, Japan. Electronic address: yamauchi5855@gmail.com. 18. Department of Nursing Science, Tenri Health Care University, 80-1, Besho-cho, Tenri-city, Nara, 632-0018, Japan. Electronic address: inamoto@tenriyorozu-u.ac.jp.
Abstract
BACKGROUND: We have developed a surgical glove (SG)-compression therapy and reported that this method significantly reduced the overall occurrence of grade 2 or higher nanoparticle albumin-bound-paclitaxel (nab-PTX)-induced peripheral neuropathy (PN) from 76.1% to 21.4%. In this multicenter single-arm confirmatory study, we investigated the efficacy and safety of SG-compression therapy for the prevention of nab-PTX-induced PN, compared with the incidence of grade 2 or higher PN in published literature as controls. PATIENTS AND METHODS: Primary breast cancer patients who received 260 mg/m2 of nab-PTX were eligible for this study. Patients wore two SGs (one size smaller than the tight-fitting size) in each hand for 90 min. PN was evaluated at each treatment cycle using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and the Patient Neurotoxicity Questionnaire (PNQ). The temperature of each fingertip was measured using thermography. RESULTS: Between October 2016 and June 2017, 58 patients were evaluated. The incidence of CTCAE grade 2 or higher PN was as low as 13.8% following SG-compression therapy. A goodness-of-fit test proved that the overall incidence of 13.8% grade 2 or higher PN in this study was comparable to the hypothesis-predicted value (13%). No adverse events, including compression intolerance or skin disorders caused by use of SG, were observed. SG-compression therapy significantly reduced the temperature of each fingertip by 1.3°C-2.3 °C compared to pre-chemotherapy level. CONCLUSIONS: This study suggested the safety and efficacy of SG-compression therapy for the amelioration of CIPN. CLINICAL TRIAL NUMBER: UMIN 000024836.
BACKGROUND: We have developed a surgical glove (SG)-compression therapy and reported that this method significantly reduced the overall occurrence of grade 2 or higher nanoparticle albumin-bound-paclitaxel (nab-PTX)-induced peripheral neuropathy (PN) from 76.1% to 21.4%. In this multicenter single-arm confirmatory study, we investigated the efficacy and safety of SG-compression therapy for the prevention of nab-PTX-induced PN, compared with the incidence of grade 2 or higher PN in published literature as controls. PATIENTS AND METHODS: Primary breast cancer patients who received 260 mg/m2 of nab-PTX were eligible for this study. Patients wore two SGs (one size smaller than the tight-fitting size) in each hand for 90 min. PN was evaluated at each treatment cycle using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and the Patient Neurotoxicity Questionnaire (PNQ). The temperature of each fingertip was measured using thermography. RESULTS: Between October 2016 and June 2017, 58 patients were evaluated. The incidence of CTCAE grade 2 or higher PN was as low as 13.8% following SG-compression therapy. A goodness-of-fit test proved that the overall incidence of 13.8% grade 2 or higher PN in this study was comparable to the hypothesis-predicted value (13%). No adverse events, including compression intolerance or skin disorders caused by use of SG, were observed. SG-compression therapy significantly reduced the temperature of each fingertip by 1.3°C-2.3 °C compared to pre-chemotherapy level. CONCLUSIONS: This study suggested the safety and efficacy of SG-compression therapy for the amelioration of CIPN. CLINICAL TRIAL NUMBER: UMIN 000024836.