Can compression or ice gloves and socks reduce neuropathy from UTD1 in advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized trial enrolling 324 women with unresectable locally advanced or metastatic breast cancer who will receive a UTD1-based regimen. Participants are assigned in a 1:1:1 ratio to a blank control, compression glove/sock, or ice glove/sock group to see if the interventions help prevent or lessen peripheral sensory and motor neuropathy. The study uses standard CTCAE criteria to assess neuropathy and safety endpoints over the course of treatment. No liver metastasis or organ dysfunction is required beyond baseline health criteria. The trial is led by Fudan University and conducted at the Fudan University Shanghai Cancer Center in Shanghai, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Ting Li — fudan university shanghai cancer center shanghai, China
• Study coordinator: Xichun Hu, MD,Phd
• Email: xchu2009@hotmail.com
• Phone: 13816110335

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.