No effective prophylactic managements are established for chemotherapy-induced peripheral neuropathy (CIPN). We developed a new, feasible method to prevent CIPN, using compression therapy with surgical gloves (SGs), called SG compression therapy, and recently 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%, as SGs decreased the microvascular flow to each fingertip (Breast Cancer Res Treat. 2016; 160:61-67). To avoid the major disadvantages of PN for the non-SG-wearing patients by a randomized controlled trial, we investigated the efficacy and safety of SG compression therapy for nab-PTX induced PN in a multicenter single-armed confirmatory study, comparing to the incidence of 44.1% grade 2 or higher PN found in known literature, which we considered as a control group.
Primary breast cancer patients who received 260 mg/m2 of nab-PTX were eligible for this study. Patients wore two SGs of the same size, i.e., one size smaller than the size that fit their both hands, for 90 minutes. PN was evaluated at each treatment cycle using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and the Patient Neurotoxicity Questionnaire (PNQ). The temperature of each fingertip was measured by using thermography.
Between October 2016 to June 2017, 61 patients were enrolled, and 58 were evaluated. The incidence of sensory PN of CTCAE grade 2 or higher was as low as 13.8% following SG compression therapy. The occurrence rate of grade 4 or higher PNQ responses, which indicate interference with activities of daily living, was also as low as 10.3%. A goodness-of-fit test using a chi-square test proved that the overall incidence of 13.8% grade 2 or higher PN obtained in this study is equal to 13% of the hypothesis-predicted value. All patients completed this study because they tolerated the compression from the SGs. SG compression therapy significantly reduced the temperature of each fingertip by 1.3–2.3 °C compared to that before chemotherapy.
This study demonstrated that SG compression therapy is effective and safe for reducing CIPN.
Clinical trial identification
University Hospital Medical Information Network (UMIN) Number: 000024836.
Legal entity responsible for the study
Kamigata Breast Cancer Study Group.
Has not received any funding.
All authors have declared no conflicts of interest.