Study of Real-time Pressure Controller Device to Prevent Peripheral Neuropathy Caused by Albumin Paclitaxel in Breast Cancer Patients

What this Trial Is About

Researchers are evaluating a new device called a real-time pressure controller designed to prevent peripheral neuropathy caused by chemotherapy with albumin paclitaxel in breast cancer patients. This device aims to improve upon existing treatments by precisely controlling pressure that gradually decreases from the fingers or toes to the wrists or limbs. The study addresses the need for a more acceptable and effective method for Chinese patients, who often have poor tolerance for current cold compresses or pressure gloves. The study compares two groups one using the real-time pressure controller device and one with no intervention. This device applies controlled pressure in a sequential manner to reduce nerve damage caused by paclitaxel chemotherapy. The study is randomized and open-label, with no masking. Its goal is to assess how well this device can reduce chemotherapy-induced peripheral neuropathy symptoms and improve patients ability to continue treatment. Participants will be monitored through various assessments including changes in tactile sensitivity and the Patient Neurotoxicity Questionnaire to evaluate the presence and severity of neuropathy. The primary outcome will be measured over about one year from the start of the study. Safety and effectiveness will be closely observed by the study team. The trial will include adults aged 18 to 75 years who are suitable for albumin paclitaxel treatment and have good overall health status.

A Study of the Effect of Real-time Pressure Controllers on Subjective and Objective Symptoms of Peripheral Neuropathy Induced by Albumin Paclitaxel