NCT07638774 The Efficacy of Compression/Ice Gloves/Socks in Patients With UTD1-induced Neuropathy.
| NCT ID | NCT07638774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Locally Advanced or Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 324 participants in total. It began in 2023-03-15 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ting Li
PRINCIPAL INVESTIGATOR
fudan university shanghai cancer center shanghai, China
Frequently Asked Questions
Who can join the NCT07638774 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Locally Advanced or Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07638774 currently recruiting?
Yes, NCT07638774 is actively recruiting participants. Contact the research team at xchu2009@hotmail.com for enrollment information.
Where is the NCT07638774 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07638774 clinical trial?
NCT07638774 is sponsored by Fudan University. The principal investigator is Ting Li at fudan university shanghai cancer center shanghai, China. The trial plans to enroll 324 participants.
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