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NCT07638774Recruiting

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

Reducing Peripheral Sensory and Motor Neuropathy Induced by UTD1 With Compression/Ice Gloves/Socks, a Multi-center Prospective Phase III Trial (YBCSG-20-02).

Source: ClinicalTrials.gov · Last updated 10 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
324 (estimated)
First submitted
1 Jul 2025
Start date
15 Mar 2023
Primary completion date
Jun 2026
Lead sponsor
Fudan University
NCT number
NCT07638774

What you commit to

  • Study type: Interventional
  • Planned participants: 324
  • From 15 Mar 2023 to the primary completion date, Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment of UTD1;
  • 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).

Other illness

  • Severe uncontrolled infection.
  • Other conditions unsuitable for the enrollment, including but not limited to illiteracy, inability to complete the peripheral neurotoxicity scale, and other neurological abnormalities affecting the accurate assessment of neurotoxicity, etc.

Other

  • Patients whose hands/feet are not suitable for wearing the compression/ice gloves/socks;

Who the study is looking for

  • 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;
  • ECOG score ≤1;
  • Adequate organ and bone marrow function defined as follows within 7 days before enrollment:
    • Absolute Neutrophil Count (ANC) ≥1,500/mm 3 (1.5 ×10 9/L), white blood cell count (WBC) ≥3.5×10 9/L, platelets ≥75,000/mm 3 (75×10 9/L), hemoglobin ≥9 g/dL (90 g/L), no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulation factor within 7 days.
    • Serum creatinine ≤1.5 × Upper Limit of Normal (ULN); AST, ALT, ALP exceeding the upper limit of normal but ≤ 2.5 × ULN when no liver metastasis; AST, ALT, ALP exceeding the upper limit of normal but ≤ 5 × ULN when liver metastasis.
  • Expected survival time ≥12 weeks;
  • No history of serious heart, lung, liver, kidney and other important organ diseases;
  • Signed informed consent;
  • Good compliance to the protocol;
  • Women of childbearing age must already be using reliable contraception, a pregnancy test (blood or urine) is performed within 14 days before enrollment and the result was negative (if positive, pregnancy must be ruled out by ultrasound), and willing to use an appropriate methods of contraception during the trial and for 8 weeks after completion of the trial.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.