Chemotherapy-induced AlopeciaICELANDNCT06011525
Prevention of Alopecia in Patients With Localised Breast Cancer
A study testing standard cold cap and scalp-cooling technique in people with Chemotherapy-induced Alopecia, run by Centre Francois Baclesse at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months and older, women only
- Conditions the study is for
- Chemotherapy-induced Alopecia
- What is being tested?
- standard cold cap and scalp-cooling technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Aug 2023to 8 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
centre François Baclesse
Caen, 14000
Centre Oscar Lambret
Lille
IUCT-Oncopole
Toulouse
About this study
Official title: Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation
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.
- Conditions
- Chemotherapy-induced Alopecia
- Being tested
- standard cold cap, scalp-cooling technique
- Keywords
- alopecia, chemotherapy-induced
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard cold capOther
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 techniqueOther
Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| standard cold-cap | Active comparator | 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. Receives: Other: standard cold cap |
| scalp-cooling technique | Experimental | 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. Receives: Other: scalp-cooling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the grade of the patient alopecia.
The grade of patient alopecia will be be evaluated by NCI-CTCAE
Measured: At 6 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start3 Aug 2023
- Primary completion3 Sep 2026 (estimated)
- Study completion8 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011525
- Sponsor's protocol ID
- 2023-A00769-36
- Acronym
- ICELAND
- Status last verified
- Jun 2026
- First submitted
- 3 Aug 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gernier F, Lequesne J, Grellard JM, Fernette M, Gigan L, Morel A, Estienne A, Castel H, Lahaye F, Leroux T, Charles RM, Dupont C, Zarca K, Dereumaux N, Rouanet AC, Durand-Zaleski I, Clarisse B. Scalp cooling versus standard cold-cap in preventing chemotherapy-induced alopecia in patients with localized breast cancer: ICELAND protocol, a randomized controlled trial and economic evaluation. PLoS One. 2026 Aug 13;21(8):e0354676. doi: 10.1371/journal.pone.0354676. eCollection 2026.
PubMed 42594101
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation
- ClinicalTrials.gov ID
- NCT06011525
- Acronym / sponsor ID
- ICELAND / 2023-A00769-36
- Conditions
- Chemotherapy-induced Alopecia
- Keywords
- alopecia, chemotherapy-induced
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 8 Sep 2028 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard cold-cap | Active comparator | Other: standard cold capPatients 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. |
| scalp-cooling technique | Experimental | Other: scalp-cooling techniquePatients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy. |
Who may qualify
- Ages
- 18 months and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- History of neck pain
- Pre-existing alopecia
- Participation in another trial
- Dermatosis of the scalp
- Contraindication to scalp cooling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard cold capStandard 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. | Other | standard cold-cap |
| scalp-cooling techniqueScalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment | Other | scalp-cooling technique |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 42594101Gernier F, Lequesne J, Grellard JM, Fernette M, Gigan L, Morel A, Estienne A, Castel H, Lahaye F, Leroux T, Charles RM, Dupont C, Zarca K, Dereumaux N, Rouanet AC, Durand-Zaleski I, Clarisse B. Scalp cooling versus standard cold-cap in preventing chemotherapy-induced alopecia in patients with localized breast cancer: ICELAND protocol, a randomized controlled trial and economic evaluation. PLoS One. 2026 Aug 13;21(8):e0354676. doi: 10.1371/journal.pone.0354676. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard cold cap and scalp-cooling technique in people with Chemotherapy-induced Alopecia, run by Centre Francois Baclesse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the grade of the patient alopecia. (time frame: At 6 months after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06011525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.