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NCT Number: NCT07638774

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

Location status: Recruiting

Location contact

Jian Zhang, PHD

CONTACT

[email protected]

021-64175590

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

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

  5. Number of participants with device-related adverse events

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Zhang, MD,Phd

CONTACT

[email protected]

18017312991

Xichun Hu, MD,Phd

CONTACT

[email protected]

13816110335

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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