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Trial Title:
Prevention of Alopecia in Patients With Localised Breast Cancer
NCT ID:
NCT06011525
Condition:
Chemotherapy-induced Alopecia
Conditions: Official terms:
Alopecia
Alopecia Areata
Conditions: Keywords:
alopecia
chemotherapy-induced
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
standard cold cap
Description:
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.
Arm group label:
standard cold-cap
Intervention type:
Other
Intervention name:
scalp-cooling technique
Description:
Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy
treatment
Arm group label:
scalp-cooling technique
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.
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.
Criteria for eligibility:
Criteria:
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
EC100 followed by 3 Docetaxel or 3 EC100 plus 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
Gender:
Female
Minimum age:
18 Months
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
centre François Baclesse
Address:
City:
Caen
Zip:
14000
Country:
France
Status:
Recruiting
Contact:
Last name:
Rose-Marie CHARLES
Email:
rm.charles@baclesse.unicancer.fr
Contact backup:
Last name:
François GERNIER
Email:
f.gernier@baclesse.unicancer.fr
Investigator:
Last name:
Rose-Marie CHARLES
Email:
Principal Investigator
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Nathalie DEREUMAUX
Email:
N-Dereumaux@o-lambret.fr
Investigator:
Last name:
Nathalie DEREUMAUX
Email:
Principal Investigator
Start date:
August 3, 2023
Completion date:
September 3, 2026
Lead sponsor:
Agency:
Centre Francois Baclesse
Agency class:
Other
Source:
Centre Francois Baclesse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011525
