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

NCT07638774 | Recruiting

• 1 other identifier: YBCSG-20-02
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (5)

• 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

  6 weeks

Study Arms (3)

blank control group

NO INTERVENTION

No intervention.

compression glove/sock group

EXPERIMENTAL

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

ice glove/sock group

EXPERIMENTAL

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

Interventions

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.

ice glove/sock group

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.

compression glove/sock group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ting Li

  fudan university shanghai cancer center shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu, MD,Phd

CONTACT

13816110335; xchu2009@hotmail.com

Jian Zhang, MD,Phd

CONTACT

18017312991; zhangjian1001@csco.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the phase I clinical trial department

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: June 10, 2026
• Study Start: March 15, 2023
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)