Prevention of Alopecia in Patients With Localised Breast Cancer
NCT ID: NCT06011525
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
196 participants
INTERVENTIONAL
2023-08-03
2028-09-08
Brief Summary
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This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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standard cold-cap
Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
This device will be supplemented by a compression bandage to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the effectiveness of the device.
standard cold cap
Standard cold-cap applied throughout anthracycline- and taxane-based chemotherapy treatment.
This device will be supplemented by a compressive bandage in order to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the efficacy of the device.
scalp-cooling technique
Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
scalp-cooling technique
Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment
Interventions
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standard cold cap
Standard cold-cap applied throughout anthracycline- and taxane-based chemotherapy treatment.
This device will be supplemented by a compressive bandage in order to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the efficacy of the device.
scalp-cooling technique
Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Months
FEMALE
No
Sponsors
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Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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centre François Baclesse
Caen, , France
Centre Oscar Lambret
Lille, , France
IUCT-Oncopole
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A00769-36
Identifier Type: -
Identifier Source: org_study_id
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