Real-time pressure controller to prevent peripheral neuropathy from albumin-bound paclitaxel
Official title: Effect of Real-time Pressure Controllers on Objective and Subjective Symptoms of Albumin Paclitaxel-induced Peripheral Neuropathy: a Prospective Controlled Research Project
Run by Tianjin Medical University Cancer Institute and Hospital · NCT07019233 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 118 (estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT07019233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China Recruiting
Study contacts
- Study coordinator: Yongsheng Jia
- Email: jiayongsheng@tjmuch.com
- Phone: （022）65150123-8212
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.