Abstract P5-14-25: A double-blind phase 2 trial of preventative use of surgical gloves for paclitaxel-induced peripheral neuropathy
Authors: Kotani Haruru , Horisawa Nanae , Sugino Kayoko , Kataoka Ayumi , Adachi Yayoi , Gondou Naomi , Yoshimura Akiyo , Hattori Masaya , Sawaki Masataka , Terada Mitsuo , Iwata Hiroji 
Published: March 2020

Background: Paclitaxel (PTX) is one of the key drugs for primary and metastatic breast cancer. The management of PTX induced peripheral neuropathy (PN) is not easy regardless of several reports about the prevention of chemotherapy-induced peripheral neuropathy (CIPN). Recently, the effectiveness of compression therapy for nanoparticle albumin-bound-paclitaxel induced PN using surgical gloves (SG) was reported from Japan. However, we consider the accurate assessment of CIPN is difficult because it is evaluated by mainly subjective symptoms, therefore, some biases such as performance bias and detection bias occurred easily. Additionally, it is difficult to confirm the reproducibility of the assessment.

In this study, we assess the effectiveness of compression therapy using SG (same procedure as previous reports) for the prevention of CIPN based on the complete blind for patients and assessing physician which means the study design to minimize the biases.

Methods: The early and recurrence breast cancer patients who started chemotherapy of weekly PTX 80mg/m2(± Trastuzumab or Bevacizumab or Pertuzumab±Trastuzumab) were enrolled. Each patient installed SG on both hands at every PTX infusion. Two one-size smaller SG was installing on one hand (study side) and two just fitted SG was installing on another hand (control side) during 90 minutes from 30 minutes before the infusion to 30 minutes after the end of the infusion. Study side and control side are blind for both patients and physicians according to the determination of the study side by research nurses in the chemotherapy unit.

The primary outcome is the difference in the frequency of CIPN (motor/sensory) between the study side and the control side determined by the physician using the CTCAE v4.0. Grade 2 or more were considered to be CIPN. The secondary outcome is the difference in the frequency of CIPN (motor/sensory) assessed by the patients using Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE). For the severity assessment, ‘moderate’ or more and for the interfering with the daily activities assessment, ’somewhat’ or more was considered as an event.

We planned sample size as follows. We assessed the frequency of more than grade2 PN in the control hand is 30% based on previous reports. According to the previous study of compression therapy, we expected 15% difference between each side with 80 % power and a significance level for a two-sided test of 0.05. We consider 5% of the dropout rate, the planned total sample size was 55 patients.

McNemar Chi-squared test was used to assess the primary and secondary outcome.

Results: Between July 11, 2017 and November 26, 2018, 56 patients were enrolled from our institution. Two patients who complained uncomfortableness of installing SG and unmatched five patients for the inclusion criteria were excluded. As a result, 49 patients were evaluated. For the patient characteristics, median age was 53, 43(87.8%) were early and 6(12.2%) were recurrence breast cancer patients. 21 patients underwent axillary dissection. At the end of the PTX regimen, Grade 2 or more PN (sensory) was observed 34.7% and 34.7% in the study and control side, respectively (McNemar p=1.0). PN (motor) was observed 24.5% and 26.5 % in the study and control side, respectively (McNemar p=1.0). No statistically significant difference of primary endpoint was observed between the control side and the study side. For the Pro-CTCAE assessment, there was also no difference between the study and control side both in the grade of numbness (McNemar p=1.0) and the effect for life. (McNemar p=1.0)

Conclusions: SG compression therapy was not effective for decreasing the incidence of PTX induced PN.

Citation Format: Haruru Kotani, Nanae Horisawa, Kayoko Sugino, Ayumi Kataoka, Yayoi Adachi, Naomi Gondou, Akiyo Yoshimura, Masaya Hattori, Masataka Sawaki, Mitsuo Terada, Hiroji Iwata. A double-blind phase 2 trial of preventative use of surgical gloves for paclitaxel-induced peripheral neuropathy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-14-25.