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

NCT04446819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-07-28

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Jian Zhang, PhD · Department of medical oncology, Fudan University Shanghai Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-12
Primary Completion
2022-01-01
Completion
2022-06-01

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446819 on ClinicalTrials.gov