The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Alopecia in Patients With Localised Breast Cancer (ICELAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06011525
Recruitment Status : Recruiting
First Posted : August 25, 2023
Last Update Posted : August 25, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 3, 2023
Estimated Primary Completion Date : September 3, 2025
Estimated Study Completion Date : September 3, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06011525


Contacts
Layout table for location contacts
Contact: Rose-Marie CHARLES +33231458648 rm.charles@baclesse.unicancer.fr
Contact: François GERNIER f.gernier@baclesse.unicancer.fr

Locations
Layout table for location information
France
centre François Baclesse Recruiting
Caen, France, 14000
Contact: Rose-Marie CHARLES       rm.charles@baclesse.unicancer.fr   
Contact: François GERNIER       f.gernier@baclesse.unicancer.fr   
Principal Investigator: Rose-Marie CHARLES         
Centre Oscar Lambret Not yet recruiting
Lille, France
Contact: Nathalie DEREUMAUX       N-Dereumaux@o-lambret.fr   
Principal Investigator: Nathalie DEREUMAUX         
Sponsors and Collaborators
Centre Francois Baclesse
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT06011525    
Other Study ID Numbers: 2023-A00769-36
First Posted: August 25, 2023    Key Record Dates
Last Update Posted: August 25, 2023
Last Verified: August 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Francois Baclesse:
alopecia
chemotherapy-induced
Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical