NCT06011525

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Aug 2023Sep 2028

First Submitted

Initial submission to the registry

August 3, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

August 3, 2023

Last Update Submit

January 12, 2026

Conditions

Chemotherapy-induced Alopecia

Keywords

alopeciachemotherapy-induced

Outcome Measures

Primary Outcomes (1)

  • Compare the grade of the patient alopecia.

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

    At 6 months after treatment start

Study Arms (2)

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.

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.

Other: scalp-cooling technique

Interventions

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.

standard cold-cap
scalp-cooling techniqueOTHER

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

scalp-cooling technique

Eligibility Criteria

Age18 Months+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Female
  • Histologically proven diagnosis of localised, non-metastatic breast cancer
  • Patient willing to be photographed to assess IFA
  • Fluency in French
  • Patient affiliated to a social security scheme
  • Signature of informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

centre François Baclesse

Caen, 14000, France

RECRUITING

Centre Oscar Lambret

Lille, France

RECRUITING

IUCT-Oncopole

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Rose-Marie CHARLES

CONTACT

+33231458648rm.charles@baclesse.unicancer.fr

François GERNIER

CONTACT

f.gernier@baclesse.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 25, 2023

Study Start

August 3, 2023

Primary Completion (Estimated)

September 3, 2026

Study Completion (Estimated)

September 8, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

FR(3)