Real-time pressure controller to prevent peripheral neuropathy from albumin-bound paclitaxel

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

This trial will test whether a real-time pressure controller can reduce numbness, tingling, and nerve pain in adults getting albumin-bound paclitaxel for breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin)
• Trial ID: NCT07019233 on ClinicalTrials.gov

What this trial studies

This interventional study uses a wearable real-time pressure controller that applies controlled, sequentially decreasing pressure from the fingertips/toes toward the wrist/ankle during albumin‑paclitaxel infusion to prevent chemotherapy-induced peripheral neuropathy. The device is designed to deliver precise, real-time pressure changes rather than static compression or cold therapy. Eligible adults with ECOG 0–1 who have not had prior chemotherapy or pre-existing neuropathy will use the device during treatment and be monitored for subjective symptoms and objective measures of neuropathy. The study is conducted at Tianjin Medical University Cancer Institute and Hospital with follow-up to track tolerability and neuropathy outcomes.

Who should consider this trial

Good fit: Adults aged 18–75 with ECOG performance status 0–1 who are planned for albumin-bound paclitaxel, have essentially normal cardiopulmonary/hepatic/renal/coagulation function, and have no prior chemotherapy or pre-existing neuropathy (including diabetes-related neuropathy) are the intended participants.

Not a fit: Patients with prior chemotherapy, existing peripheral neuropathy, diabetes or other neuropathy-causing comorbidities, or those outside the 18–75 age range are unlikely to benefit from this prevention device.

Why it matters

Potential benefit: If successful, the device could reduce the severity or incidence of paclitaxel-induced peripheral neuropathy and help patients complete planned chemotherapy with fewer symptoms.

How similar studies have performed: Prior approaches such as cryotherapy and compression garments have shown mixed or limited benefit for preventing chemotherapy-induced neuropathy, and real-time sequential pressure controllers are a novel approach with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily signed written informed consent;
2. Age ≥18 years and ≤75 years at enrollment, male or female patients;
3. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
4. Suitable for albumin-paclitaxel antitumor therapy;
5. Cardiopulmonary, hepatic, renal, and coagulation functions are basically normal.

Exclusion Criteria:

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

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Yongsheng Jia

Conditions Real Time Pressure Controller; Breast Cancer; Albumin Paclitaxel; Peripheral Neuropathy