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Prevention of Alopecia in Patients With Localised Breast Cancer

NCT06011525 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-01-13

No results posted yet for this 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.

Conditions

  • Chemotherapy-induced Alopecia

Interventions

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.

OTHER

scalp-cooling technique

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

Sponsors & Collaborators

  • Centre Francois Baclesse

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2026-09-03
Completion
2028-09-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011525 on ClinicalTrials.gov