Clinical trial · Observational
Efficacy of the Use of Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Breast Cancer
Efficacy of the Use of a Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Locally Advanced or Metastatic Breast Cancer Pretreated With Anthracyclines and Taxanes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Alopecia grade after 3 cycles of eribulin according to NCI-CTCAE v4.0
- timeFrame
- on the day 1 of cycle 4
- description
- Efficacy of the refrigerant helmet : Alopecia grade after 3 cycles of eribulin
Secondary outcomes (1)
- measure
- Adverse events graded according to NCI-CTCAE v4.0
- timeFrame
- every 28 days : at day 1 of each cycle during 3 cycles
- description
- Tolerance of the refrigerant helmet : graduation of adverse events lived by patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patient who has a locally advanced or metastatic breast cancer * Indication of Halaven treatment : patient pretreated with anthracyclines or taxanes, patient who has received at least 1 chemotherapy regimen for their advanced or metastatic stage * Patient who has had enough time to have retrieved her hair or whose last chemotherapy regimen didn't induce alopecia. * Aged ≥ 18 years * Non-opposition of the patient must have been collected Exclusion Criteria: * Skin metastasis of the scalp * Sensitivity to cold, cold agglutinin disease or cryoglobulinemia * Impossibility to submit at the study procedures due to geographic, social or mental reasons
References
Publications (0)
Data not yet available