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

Tianjin Medical University

Status: Enrolling

Conditions: Breast Cancer; Peripheral Neuropathy; Real Time Pressure Controller; Albumin Paclitaxel

Treatments: Device: Real Time Pressure Controller

Study type: Interventional

Funder types: Other

Identifiers

NCT07019233

TJIA2025

Details and patient eligibility

About

The purpose of the real-time pressure controller proposed in this experiment is to overcome the deficiencies of the existing technology and provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, with the pressure decreasing in a sequential manner from the distal end (toes/fingers) to the proximal end (wrists, limbs). The application of this device is of great clinical significance to reduce the peripheral neurotoxicity of paclitaxel and to improve patients' drug compliance. The application of cold compresses or gloves or socks with certain wrapping force is not suitable for the Chinese population, and the acceptance degree of Chinese patients is poor, and the pressure gloves lack individual specificity, and the precise control of pressure for real-time regulation cannot be realized, and the clinical effect is relatively poor. The purpose of this utility model device is to overcome the deficiencies of the existing technology, to provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, and the pressure decreases in a sequential manner from the distal end (toes/fingers) to the proximal end (wrist, limb). After applying for the patent, it will be transformed into the market, which has a vast space of medical benefits and market benefits. Paclitaxel is the cornerstone drug in breast cancer chemotherapy, and the neuropathy it causes is often a key factor leading to drug reduction or discontinuation, so opening up the prevention of peripheral neuropathy caused by paclitaxel is of great clinical use.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily signed written informed consent;
2. Age ≥18 years and ≤75 years at enrollment, male or female patients;
3. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
4. Suitable for albumin-paclitaxel antitumor therapy;
5. Cardiopulmonary, hepatic, renal, and coagulation functions are basically normal.

Exclusion criteria

1. Patients with prior chemotherapy;
2. Patients with a prior diagnosis of peripheral neuropathy;
3. Patients with a prior diagnosis of associated comorbidities (e.g., diabetes mellitus).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

No intervention

No Intervention group

two-handed intervention

Experimental group

Treatment:

Device: Real Time Pressure Controller