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NCT Number: NCT07019233

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location status: Recruiting

Location contact

Yongsheng Jia

CONTACT

[email protected]

(022)65150123-8212

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily signed written informed consent;
  • Age ≥18 years and ≤75 years 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.

Exclusion criteria

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

Treatment and study plan

Real Time Pressure Controller

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.

Primary outcomes

  1. CIPN-related symptoms, as assessed by changes in tactile sensitivity at pretreatment baseline CIPN incidence.The Patient Neurotoxicity Questionnaire (PNQ) was used to assess and grade the incidence and severity of CIPN.

    Time frame: through study completion, an average of 1 year

    From the time a patient begins albumin paclitaxel therapy until the patient's treatment on this regimen is completed, or during albumin paclitaxel therapy, adverse reactions due to pressure gloves that result in patient patient disenrollment or voluntary.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongsheng Jia

CONTACT

[email protected]

(022)65150123-8212

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

Effect of Real-time Pressure Controllers on Objective and Subjective Symptoms of Albumin Paclitaxel-induced Peripheral Neuropathy: a Prospective Controlled Research Project

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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