Cold war on baldness: which scalp cooling method wins for breast cancer patients?
NCT ID NCT06011525
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two ways to cool the scalp during chemotherapy to prevent hair loss in women with localized breast cancer. One uses a standard cold cap with a compression bandage, the other a cooling mask. Researchers will compare how well each prevents hair loss, and also look at quality of life, self-image, and costs. The goal is to find which technique works best and is most worth using.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- scalp cooling device (cold cap or cooling mask)
- What this could lead to
- If successful, this could provide a better, more effective way to prevent chemotherapy-induced hair loss, improving quality of life for breast cancer patients.
- What could go wrong
- This is a moderate-sized trial (196 participants) comparing two existing techniques, not a new breakthrough. Results may show only modest differences, and effectiveness varies by individual.
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 196 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Sep 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 months and older
- 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: * Age \>18 * Female * Histologically proven diagnosis of localised, non-metastatic breast cancer * Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 or 4 EC100 followed by 3 Docetaxel or 3 or 4 EC100 plus 9 to 12 Paclitaxel); HER-positive status is not a non-inclusion criterion. * Patient willing to be photographed to assess IFA * Fluency in French * Patient affiliated to a social security scheme * Signature of informed consent Exclusion Criteria: * History of neck pain * Pre-existing alopecia * Participation in another trial * Dermatosis of the scalp * Contraindication to scalp cooling * History of migraines, stroke or hyperthyroidism * History of scalp metastases * Sensitivity to cold, cold agglutinin disease, cryoglobulinaemia, cryofibrinogenaemia or post-traumatic cold dystrophy. * Malignant haemopathies * History of chemotherapy treatment * Indication for cerebral irradiation * Pregnant or breast-feeding patient * Raynaud's syndrome
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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.
Contacts and locations
Locations
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Centre Oscar Lambret
Lille, France
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IUCT-Oncopole
Toulouse, France
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centre François Baclesse
Caen, 14000, France
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Other studies related to the condition(s) this trial covers.
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