NCT04446819

Compression Gloves to Reduce Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity (REMAINING)

A Multicenter Prospective Phase III Clinical Study of Reducing Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity of Upper Extremities With Compression Gloves (REMAINING)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Nanoparticle albumin-bound paclitaxel has greater efficacy and favorable safety profile than standard paclitaxel. However, rate of neuropathy caused by nanoparticle albumin-bound paclitaxel is higher than standard paclitaxel, and is one of its dose-limited toxicities. Previously, compression therapy by surgical gloves has shown effectiveness in preventing chemotherapy-induced neuropathy. We designed this multi-center prospective self-control phase III study to investigate the efficacy of compression gloves to reduce albumin-binding paclitaxel induced sensory and motor neurotoxicity of upper extremities.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Compression gloves	Patients wear small-size compression gloves (one or two size smaller than suitable size) for dominant hands and suitable-size compression gloves for non-dominant hands for 90 minutes during the administration of albumin-binding paclitaxel (start from 30 minutes before albumin-binding paclitaxel infusion).

Timeline

• Start date: 2020-07-12
• Primary completion: 2022-01-01
• Completion: 2022-06-01
• First posted: 2020-06-25
• Last updated: 2020-07-28

Locations

1 site across 1 country: China