Prevention of Alopecia in Patients With Localised Breast Cancer

The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy.

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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Key information

Conditions

Chemotherapy-induced Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 month and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

centre François Baclesse, Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard cold cap

Other

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

Other

Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment

Primary outcomes

Compare the grade of the patient alopecia.

Time frame: At 6 months after treatment start

The grade of patient alopecia will be be evaluated by NCI-CTCAE

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study title

Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation

Acronym: ICELAND

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2028
First posted: Aug 25, 2023
Registry last updated: Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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