Actively Recruiting
Effect of Real-time Pressure Controllers on Symptoms of Albumin Paclitaxel-induced Peripheral Neuropathy: A Prospective Controlled Study
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-06-13
118
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new device called a real-time pressure controller designed to prevent peripheral neuropathy caused by chemotherapy with albumin paclitaxel in breast cancer patients. This device aims to improve upon existing treatments by precisely controlling pressure that gradually decreases from the fingers or toes to the wrists or limbs. The study addresses the need for a more acceptable and effective method for Chinese patients, who often have poor tolerance for current cold compresses or pressure gloves. The study compares two groups: one using the real-time pressure controller device and one with no intervention. This device applies controlled pressure in a sequential manner to reduce nerve damage caused by paclitaxel chemotherapy. The study is randomized and open-label, with no masking. Its goal is to assess how well this device can reduce chemotherapy-induced peripheral neuropathy symptoms and improve patients' ability to continue treatment. Participants will be monitored through various assessments including changes in tactile sensitivity and the Patient Neurotoxicity Questionnaire to evaluate the presence and severity of neuropathy. The primary outcome will be measured over about one year from the start of the study. Safety and effectiveness will be closely observed by the study team. The trial will include adults aged 18 to 75 years who are suitable for albumin paclitaxel treatment and have good overall health status.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Voluntarily signed written informed consent
- Age 18 to 75 years, male or female
- 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
You will not qualify if you...
- Prior chemotherapy treatment
- Previous diagnosis of peripheral neuropathy
- Diagnosis of associated comorbidities such as diabetes mellitus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of albumin-paclitaxel chemotherapy treatment
Participants assigned to the experimental group receive the real-time pressure controller device during their chemotherapy treatment to help prevent peripheral neuropathy.
Duration - Up to 1 year following treatment
Participants are monitored for changes in symptoms of peripheral neuropathy and other outcomes throughout the study period.
Regular assessments during and after treatment
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Actively Recruiting
Research Team
Y
Yongsheng Jia
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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