Chilling out Chemo's side effects: could cold therapy shield nerves?
NCT ID NCT07780955
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial tests whether applying cooling cuffs to the hands and feet during weekly paclitaxel chemotherapy can reduce nerve damage in women with breast cancer. Participants are randomly assigned to receive cryotherapy or standard care, and their nerve function is tracked through exams, nerve tests, and questionnaires over a year. The goal is to see if this simple, non-drug approach can lower the risk of painful numbness and tingling that often forces patients to reduce or stop treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cryotherapy using a device that cools the hands and feet during chemotherapy
- What this could lead to
- If effective, cooling the hands and feet during chemo could become a simple way to prevent nerve damage, helping patients complete treatment with fewer side effects.
- What could go wrong
- This is an early-stage trial, and the cooling may not reduce nerve damage for everyone. It could also cause discomfort or cold-related skin issues.
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 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 2028
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 90 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: * Paclitaxel weekly (80 mg/m2) at least 12 cycles (in adjuvant, neo-adjuvant setting or metastatic setting following the present schemes: TH (Paclitaxel, Trastuzumab), AC-TH (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab), AC-THP (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab, Pertuzumab), AC-T (Doxorubicin, Cyclophosphamide, Paclitaxel) * Eastern Cooperative Oncology Group Performance Status (ECOG) \< 2 * Female sex * Age: 18-90 years * written informed consent Exclusion Criteria: * pre-existing motor/sensitive peripheral neuropathy * diabetes * Endocrinopathies * presence of brain, bone, soft tissue, or skin of hands or feet metastases * Raynaud's syndrome * Peripheral arterial disease * hand and foot syndrome * any other reason that may hamper the data collection as assessed by the examiner
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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
4 sites. 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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Ospedale di Bolzano
NOT_YET_RECRUITINGBolzano, Bolzano, Italy
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Ospedale di Bressanone
RECRUITINGBrixen, Bolzano, 39042, Italy
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Ospedale di Brunico
RECRUITINGBruneck, Bolzano, 39031, Italy
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Ospedale di Merano
RECRUITINGMerano, Bolzano, Italy
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Other studies related to the condition(s) this trial covers.
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- Mind and body: does resilience leave a molecular mark in breast cancer?
- Which pain block works better for breast surgery?
- Can a Triple-Drug combo erase HER2-Positive breast tumors before surgery?
- Bacteria inside tumors may hold the key to breast cancer treatment
- Can a newer drug ease the bone pain of chemotherapy support?