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).

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced or Metastatic Breast Cancer
• Intervention / Treatment: Device: compression glove/sock; Device: ice glove/sock

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xichun Hu, MD,Phd; Phone Number: 13816110335; Email: xchu2009@hotmail.com
• Study Contact Backup: Name: Jian Zhang, MD,Phd; Phone Number: 18017312991; Email: zhangjian1001@csco.ac.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Jian Zhang, PHD; Phone Number: 021-64175590; Email: syner2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female ，18-75 years;
2. Documentation of histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer;
3. The participants is going to receive UTD1 based regimen at least 2 cycles；
4. The baseline peripheral sensory neuropathy and peripheral motor neuropathy (CTCAE 5.0) is less than 1 grade;
5. ECOG score ≤1;

6. 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.

7. Expected survival time ≥12 weeks;
8. No history of serious heart, lung, liver, kidney and other important organ diseases;
9. Signed informed consent;
10. Good compliance to the protocol;
11. 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 Criteria:

1. Previous treatment of UTD1;
2. Severe uncontrolled infection.
3. 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).
4. Patients whose hands/feet are not suitable for wearing the compression/ice gloves/socks;
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: blank control group; No intervention.
Experimental: compression glove/sock group; 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.	Device: compression 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.
Experimental: ice glove/sock group; 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.	Device: ice 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in the incidence of ≥ grade 2 peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in incidence of total peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.		6 weeks
Difference in the incidence of ≥grade 2 peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.		6 weeks
Difference in incidence of total peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.		6 weeks
Differences in peripheral neurotoxicity scale scores assessed by Functional Assessment of Cancer Therapy-breast after 2 cycles of UTD1 treatment.treatment.		6 weeks
Number of participants with device-related adverse events	Number of participants experiencing adverse events related to the use of cryotherapy gloves/socks or compression gloves/socks, including skin injury, pain, discomfort, cold intolerance, numbness, and other device-related adverse events, assessed according to CTCAE v5.0.	6 weeks

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Ting Li, fudan university shanghai cancer center shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 1, 2025
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: YBCSG-20-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No