Prevention of Alopecia in Patients With Localised Breast Cancer

Last updated: August 27, 2024
Sponsor: Centre Francois Baclesse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alopecia

Hair Loss

Treatment

standard cold cap

scalp-cooling technique

Clinical Study ID

NCT06011525
2023-A00769-36
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18

  • Female

  • Histologically proven diagnosis of localised, non-metastatic breast cancer

  • Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3EC100 followed by 3 Docetaxel or 3 EC100 plus 12 Paclitaxel); HER-positive status isnot 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

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, cryofibrinogenaemiaor post-traumatic cold dystrophy.

  • Malignant haemopathies

  • History of chemotherapy treatment

  • Indication for cerebral irradiation

  • Pregnant or breast-feeding patient

  • Raynaud's syndrome

Study Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: standard cold cap
Phase:
Study Start date:
August 03, 2023
Estimated Completion Date:
September 03, 2026

Connect with a study center

  • centre François Baclesse

    Caen, 14000
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille,
    France

    Site Not Available

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