Simple gloves and socks may shield breast cancer patients from chemo nerve pain
NCT ID NCT07638774
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether wearing compression or ice gloves and socks can reduce nerve damage caused by the chemotherapy drug UTD1 in women with advanced breast cancer. 324 participants will be randomly assigned to wear nothing, compression gloves/socks, or ice gloves/socks during treatment. The goal is to see if these simple devices lower the risk of painful or numb hands and feet.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- compression glove/sock and ice glove/sock
- What this could lead to
- If it works, this could offer a simple, low-cost way to prevent chemotherapy-induced nerve damage, improving quality of life for breast cancer patients.
- What could go wrong
- This is a phase 3 trial, but the intervention is a device, not a drug, so the effect may be modest. It may not work for everyone, and results may not apply to other chemotherapy drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 324 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, China
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