A Study of the Effect of Real-time Pressure Controllers on Subjective and Objective Symptoms of Peripheral Neuropathy Induced by Albumin Paclitaxel
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Real Time Pressure Controller.
- Who it may be relevant to
- Registry conditions: Real Time Pressure Controller, Breast Cancer, Albumin Paclitaxel, Peripheral Neuropathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Real-time Pressure Controllers on Objective and Subjective Symptoms of Albumin Paclitaxel-induced Peripheral Neuropathy: a Prospective Controlled Research Project
Overview
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.
Interventions
- Device 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 neuro
Primary outcome measures
- 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]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Cancer Institute and Hospital — Tianjin
Identifiers
NCT: NCT07019233 · TJIA2025