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The Efficacy of Compression/Ice Gloves/Socks in Patients With UTD1-induced Neuropathy.

ConditionLocally Advanced or Metastatic Breast Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • compression glove/sock

    Device

    Patients in group B wear pressure gloves/socks of a smaller size for both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.

  • ice glove/sock

    Device

    Patients in group C wear ice gloves/socks on both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.

Treatment groups

324 Participants
are divided into 3 treatment groups
Group A: blank control groupNo intervention 0 interventions
Group B: compression glove/sock groupExperimental treatment 1 intervention
Group C: ice glove/sock groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Difference in the incidence of ≥ grade 2 peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment

Time frame
6 weeks

Secondary outcomes

1

Difference in incidence of total peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.

Time frame
6 weeks
2

Difference in the incidence of ≥grade 2 peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.

Time frame
6 weeks
3

Difference in incidence of total peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.

Time frame
6 weeks
4

Differences in peripheral neurotoxicity scale scores assessed by Functional Assessment of Cancer Therapy-breast after 2 cycles of UTD1 treatment.treatment.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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Fudan University

Lead sponsor

Source ClinicalTrials.gov
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