Status:
COMPLETED
Shorter Scalp Cooling Time in Paclitaxel
Lead Sponsor:
Leiden University Medical Center
Conditions:
Neoplasm Malignant
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects for patients. Scalp cooling can prevent or minimise CIA in approximately half of all patients, depending on many factors...
Eligibility Criteria
Inclusion
- Patients receiving weekly-administered paclitaxel-containing chemotherapy (minimal 3 planned administrations) in a dose of 80-90 mg/m2 Paclitaxel monotherapy, Paclitaxel in combination with carboplatin, Paclitaxel in combination with monoclonal antibodies: Bevacizumab or Trastuzumab
- Age ≥ 18 years
- WHO performance status 0-2
- Survival expectation must be \> 3 months
- Written informed consent according to the local Ethics Committee requirements
Exclusion
- Treatment with paclitaxel in sequential schemes with other alopecia inducing agents such as paclitaxel monotherapy after adriamycin, cyclophosphamide (AC) or paclitaxel monotherapy after 5-fluouracil, epirubicin, cyclophosphamide (FEC) treatment
- Alopecia before the start of the study
- Rare cold-related disorders: Cold sensitivity, Cold agglutinin disease, Cryoglobulinaemia, Cryofibrinogenaemia, Cold posttraumatic dystrophy
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2020
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03266185
Start Date
December 20 2017
End Date
August 28 2020
Last Update
April 1 2021
Active Locations (1)
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1
LUMC
Leiden, Netherlands