The Efficacy of Compression/Ice Gloves/Socks in Patients With UTD1-induced Neuropathy.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University
About this trial
This study is a prospective, multicenter, phase Ⅲ trial to evaluate of the compression/ice gloves/socks efficacy in UTD1-induced peripheral sensory and motor neuropathy. 324 patients will be included. All patients will be randomly divided into three groups at a ratio of 1:1:1. Group A is the blank control group, group B is the compression glove/sock group, and group C is the ice glove/sock group.
Eligibility criteria
Qualifiers
Female ，18-75 years;
Documentation of histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer;
The participants is going to receive UTD1 based regimen at least 2 cycles；
The baseline peripheral sensory neuropathy and peripheral motor neuropathy (CTCAE 5.0) is less than 1 grade;
Disqualifiers
Previous treatment of UTD1;
Severe uncontrolled infection.
Patients with leptomeningeal metastases, symptomatic brain metastases, spinal cord compression, or brain or leptomeningeal disease detected on imaging at screening (patients who had completed local brain therapy 21 days before treatment and had stable symptoms and no cerebral hemorrhage confirmed by imaging were eligible).
Patients whose hands/feet are not suitable for wearing the compression/ice gloves/socks;
Trial design
Treatments tested in this trial
- compression glove/sock
- ice glove/sock
Treatment groups
324 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov