Compression therapy using surgical gloves does not prevent paclitaxel-induced peripheral neuropathy: results from a double-blind phase 2 trial

Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of paclitaxel (PTX). There is no known prophylactic measure, although there are some reports of prevention with compression therapy using surgical gloves. On account of its predominantly subjective symptoms, it is difficult to exclude bias when assessing for CIPN. In this study, we assessed the effectiveness of the same procedure for the prevention of paclitaxel-induced PN based on a double-blind study design.

Methods: The patients with early and recurrent breast cancer (with no prior PTX exposure) initiating weekly chemotherapy with PTX 80 mg/m² were enrolled. Each patient donned two gloves on each hand at every PTX infusion. Two one-size-smaller gloves were donned on one hand (study side) and two normal-size gloves were donned on the other hand (control side) during 90 min from 30 min before the infusion to 30 min after the end of the infusion. Study side are blind for both patients and assessing physicians according to determination of the study side by research nurses in the chemotherapy unit. The primary outcome was the difference in the frequency of CIPN (motor/sensory) determined by the physician using the common terminology criteria for adverse events (CTCAE v4.0), with an evaluation at each cycle of PTX infusion. McNemar test was used to assess the primary outcome.

Results: Between July 2017 and November 2018, 56 patients were enrolled and 49 patients were evaluated. Overall, Grade ≥ 2 PN (sensory) was observed in 30.6 and 36.7% in the study and control sides, respectively (McNemar p = 0.25). PN (motor) was observed in 4.1 and 6.1% in the study and control sides, respectively (McNemar p = 1.0).

Conclusion: Surgical glove compression therapy showed no statistically significant effect on the incidence of PTX-induced PN.

Trial registrations: This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry managed by the National University Hospital Council of Japan ( UMIN000027944 ). Registered 26 June 2017.

Keywords: Breast cancer; Chemotherapy-induced peripheral neuropathy; Paclitaxel; Prevention; Surgical gloves.

Fig. 1

Primary outcome: difference in the frequency of CIPN (motor/sensory). At the final assessed point, Grade ≥ 2 or more PN (sensory) was observed in 30.6 and 36.7% patients on the study and control side, respectively (McNemar p = 0.25). PN (motor) was observed in 4.1 and 6.1% on the study and control side, respectively (McNemar p = 1.0). No statistically significant difference in primary endpoints was observed between the control side and the study side

Fig. 2

Secondary outcome: difference in the frequency of CIPN assessed using PRO-CTCAE. The questionnaire completion rate was 85.2%. There was no difference between the study and control sides in either the severity of numbness (McNemar p = 1.0) or interference with daily activities. (McNemar p = 1.0)

Fig. 3

Temperature changes in each fingertip. For the study side, the temperature of all fingertips was decreased (1.1–2.7 °C). For the control side, the temperature change was relatively small (− 0.23 − + 0.99 °C). p = 0.0004 (* first digit), 0.0508 († second digit), 0.1226 (‡ third digit), 0.0136 (§fourth digit), and0.0020 (|| fifth digit)