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

Primary Purpose

Chemotherapy-induced Alopecia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standard cold cap
scalp-cooling technique
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Alopecia focused on measuring alopecia, chemotherapy-induced

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • centre François BaclesseRecruiting
  • Centre Oscar Lambret

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard cold-cap

scalp-cooling technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 21, 2023
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT06011525
Brief Title
Prevention of Alopecia in Patients With Localised Breast Cancer
Acronym
ICELAND
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
September 3, 2025 (Anticipated)
Study Completion Date
September 3, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Alopecia
Keywords
alopecia, chemotherapy-induced

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard cold-cap
Arm Type
Active Comparator
Arm Description
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.
Arm Title
scalp-cooling technique
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
standard cold cap
Intervention 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.
Intervention Type
Other
Intervention Name(s)
scalp-cooling technique
Intervention Description
Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment
Primary Outcome Measure Information:
Title
Compare the grade of the patient alopecia.
Description
The grade of patient alopecia will be be evaluated by NCI-CTCAE
Time Frame
At 6 months after treatment start

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rose-Marie CHARLES
Phone
+33231458648
Email
rm.charles@baclesse.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
François GERNIER
Email
f.gernier@baclesse.unicancer.fr
Facility Information:
Facility Name
centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rose-Marie CHARLES
Email
rm.charles@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
François GERNIER
Email
f.gernier@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Rose-Marie CHARLES
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie DEREUMAUX
Email
N-Dereumaux@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Nathalie DEREUMAUX

12. IPD Sharing Statement

Learn more about this trial

Prevention of Alopecia in Patients With Localised Breast Cancer

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