RecruitingNot ApplicableNCT07638774

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).


Sponsor

Fudan University

Enrollment

324 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria13

  • 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.

Exclusion Criteria5

  • 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;
  • 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.

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Interventions

DEVICEcompression glove/sock

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.

DEVICEice glove/sock

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.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07638774


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