Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07019233

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

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-06-13

118

Participants Needed

1

Research Sites

121 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily signed written informed consent
  • Age 18 years and older and 75 years or younger at enrollment
  • Male or female patients
  • Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1
  • Suitable for albumin-paclitaxel antitumor therapy
  • Cardiopulmonary, hepatic, renal, and coagulation functions are basically normal
Not Eligible

You will not qualify if you...

  • Patients with prior chemotherapy
  • Patients with a prior diagnosis of peripheral neuropathy
  • Patients with a prior diagnosis of associated comorbidities (e.g., diabetes mellitus)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Actively Recruiting

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Research Team

Y

Yongsheng Jia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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