title: The effectiveness of regional cooling for paclitaxel-induced peripheral neuropathy.
abstract: BACKGROUND
  There are currently no promising therapies available to treat or prevent peripheral neuropathy (PN) induced by anticancer drugs in a cumulative dose-dependent manner. In this study, we investigated the efficacy of regional cooling of hands and feet in preventing paclitaxel (PTX)-induced PN.
  
  
  METHODS
  Patients with gynecologic cancer who received a tri-weekly cycle of chemotherapy including PTX at doses of 150-175 mg/m2were included in this study. Regional cooling was performed by covering patient hands and feet with cold insulators during PTX administration (regional cooling group). The primary end-point was ≥grade 2 PN evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The secondary end-points were the frequency of PN therapeutic drug use, PTX dose reduction due to PN, and adverse events due to regional cooling. The efficacy of regional cooling was compared with data retrospectively extracted from the medical records of patients who did not receive regional cooling (control group). All end-points were evaluated for up to six cycles.
  
  
  RESULTS
  There were 40 and 142 patients in the regional cooling and control groups, respectively. As a primary end-point, incidences of ≥grade 2 PN in the fourth to sixth cycles were significantly lower than that in the cooling group (5.0-9.1 % vs. 19.8-31.6 %,p< 0.05 after the fourth cycle andp< 0.01 after the fifth cycle). Among secondary end-points, neither the use of PN therapeutic drugs nor the PTX dose reduction due to PN were significantly lower in the cooling group than in the control group (27.5 vs. 36.6 %,p= 0.378 and 5.0 vs. 3.5 %,p= 0.645, respectively). There were no serious regional cooling-associated adverse events such as frostbite.
  
  
  CONCLUSIONS
  Regional cooling of hands and feet during PTX administration might have good effectiveness and tolerability, suggesting this approach as a potentially effective supportive care to prevent PTX-induced PN.
  
  
  BACKGROUND
  The trial approval number in the institution; H25-26. Registered 5 June 2014.
authors.affiliation: Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan ; Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Sato
authors.affiliation: Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan.
authors.forename: Megumi
authors.initials: M
authors.lastname: Mori
authors.affiliation: Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan ; Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Nihei
authors.affiliation: Department of Nursing, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan.
authors.forename: Masumi
authors.initials: M
authors.lastname: Kumagai
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takeuchi
authors.affiliation: Department of Breast Surgery, Breastpia Miyazaki Hospital, 2-112-1 Maruyama, Miyazaki, Miyazaki, 880-0052 Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kashiwaba
authors.affiliation: Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan ; Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan.
authors.forename: Kenzo
authors.initials: K
authors.lastname: Kudo
keywords: Chemotherapy; Gynecologic cancer; Paclitaxel; Peripheral neuropathy; Regional cooling