Cold gloves and squeeze: new combo may shield nerves during chemo
NCT ID NCT06400849
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using a frozen glove plus a tight surgical glove on one hand works better than a frozen glove alone to prevent nerve damage caused by the chemotherapy drug paclitaxel. About 60 women with early-stage breast cancer will be enrolled, each acting as their own control. The goal is to reduce numbness, tingling, and pain that can last long after treatment ends.
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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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jun 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 99 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient age ≥ 18 years ; * Performance Status (PS): 0 to 2 * Women with localised or locally advanced breast cancer of any histology * Indication for treatment with 3 to 4 cycles of paclitaxel (+/- trastuzumab, pertuzumab, carboplatin or endoxan) as adjuvant or neoadjuvant therapy. The choice of the number of cycles will be at the investigator's discretion. * Symmetry of upper limb peripheral neuropathy grade ≤ 1 according to CTCAE version 5.0 at inclusion. * Presence of radial pulses in the upper limbs. * Presence of tibio-posterior and tibio-anterior ankle pulses or ankle systolic pressure index \> 0.9. * Patient has read the information note and signed the informed consent form. * The patient is covered by social security. Exclusion Criteria: * Patient age \< 18 years * Patients diagnosed with metastatic or bilateral breast cancer * Patients with metastatic disease of any location * Peripheral neuropathy grade ≥ 2 according to CTCAE version 5.0 of the upper or lower limbs * Patients with asymmetric upper limb peripheral neuropathy grade \> 1 according to CTCAE version 5.0 at inclusion. \*In the case of asymmetry of the lower limbs of grade \> 1 according to CTCAE version 5.0, the patient will not be considered a failure in selection but the corresponding secondary criteria will not be analysed. * Patients with underlying medical conditions that could potentially cause peripheral neuropathy (diabetes mellitus, chronic alcoholism, unilateral lymphoedema or postherpetic neuralgia), or any other reason based on the investigator's judgement. * Diagnosed Raynaud's syndrome * Obstructive arterial disease of the lower limbs * History of myocardial infarction * Patients already using compression foot socks * Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017: * Pregnant women * Incapacitated participants who have not given their free and informed consent or refused to do so before the onset of their incapacity, who do not fall under the provisions of Article 64 ; * Pregnant or breast-feeding women who are not covered by the provisions of article 66; * Persons of full age who are the subject of a legal protection measure or who are unable to express their consent.
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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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Centre Antoine Lacassagne
RECRUITINGNice, 06189, France
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