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

NCT ID: NCT07019233

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

two-handed intervention

Group Type: EXPERIMENTAL

Real Time Pressure Controller

Intervention Type: DEVICE

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.

Interventions

Real Time Pressure Controller

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongsheng Jia

Role: CONTACT

jiayongsheng@tjmuch.com

（022）65150123-8212

Facility Contacts

Yongsheng Jia

Role: primary

jiayongsheng@tjmuch.com

（022）65150123-8212

Other Identifiers

TJIA2025

Identifier Type: -

Identifier Source: org_study_id