ICELAND: Prevention of Alopecia in Patients With Localised Breast Cancer

Sponsor

Centre Francois Baclesse (Other)

Overall Status

Recruiting

CT.gov ID

NCT06011525

Collaborator

(none)

196

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Alopecia	Other: standard cold cap Other: scalp-cooling technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Aug 3, 2023

Anticipated Primary Completion Date :

Sep 3, 2025

Anticipated Study Completion Date :

Sep 3, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	Other: scalp-cooling technique Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment

Arm

Intervention/Treatment

Active Comparator: 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.

Other: 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.

Experimental: 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.

Other: scalp-cooling technique

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

Outcome Measures

Primary Outcome Measures

Compare the grade of the patient alopecia. [At 6 months after treatment start]
The grade of patient alopecia will be be evaluated by NCI-CTCAE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	centre François Baclesse	Caen		France	14000
2	Centre Oscar Lambret	Lille		France

Sponsors and Collaborators

Centre Francois Baclesse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Francois Baclesse

ClinicalTrials.gov Identifier:

NCT06011525

Other Study ID Numbers:

2023-A00769-36

First Posted:

Aug 25, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Francois Baclesse

alopecia

chemotherapy-induced

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

Study Results

No Results Posted as of Aug 25, 2023