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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Yongsheng Jia
jiayongsheng@tjmuch.com
(022)65150123-8212
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 118
Treatments
No_intervention: No intervention
Experimental: two-handed intervention
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov