Actively Recruiting

Phase Not Applicable
Age: 18Months +
FEMALE
NCT06011525

Prevention of Alopecia in Patients With Localised Breast Cancer

Led by Centre Francois Baclesse · Updated on 2026-01-13

196

Participants Needed

3

Research Sites

266 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prevention of Alopecia in Patients With Localised Breast Cancer

Who Can Participate

Age: 18Months +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18
  • Female
  • Histologically proven diagnosis of localized, non-metastatic breast cancer
  • Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 or 4 EC100 followed by 3 Docetaxel or 3 or 4 EC100 plus 9 to 12 Paclitaxel); HER-positive status allowed
  • Patient willing to be photographed to assess alopecia
  • Fluency in French
  • Patient affiliated to a social security scheme
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • 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 blood diseases
  • History of chemotherapy treatment
  • Indication for cerebral irradiation
  • Pregnant or breastfeeding
  • Raynaud's syndrome

AI-Screening

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Trial Site Locations

Total: 3 locations

1

centre François Baclesse

Caen, France, 14000

Actively Recruiting

2

Centre Oscar Lambret

Lille, France

Actively Recruiting

3

IUCT-Oncopole

Toulouse, France

Not Yet Recruiting

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Research Team

R

Rose-Marie CHARLES

CONTACT

F

François GERNIER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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