Trial Information
A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
Inclusion Criteria:
- Any solid tumor malignancy receiving docetaxel (Taxotere®) 1st line chemotherapy
treatment with the exception of regimen containing concomitant anthracycline
treatment; sequential anthracycline/docetaxel treatment is permitted.
- Performance Status ECOG <= 2
- Absence of alopecia at inclusion
Exclusion Criteria:
- Chemotherapy regimen including concomitant anthracycline treatment
- Raynaud's disease or phenomenon
- Cold agglutinin disease
- Cryoglobulinemia
- Cryofibrinogenemia
- Scalp metastasis
- Pregnancy or Lactation
- Preexisting alopecia of any grade; notably androgenetic alopecia
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Grade III or IV alopecia according to the WHO criteria
Outcome Time Frame:
D1 of each cycle and D+21 after last cycle of chemotherapy
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Switzerland: Ethikkommission
Study ID:
DOCET_L_04449
NCT ID:
NCT01008774
Start Date:
July 2009
Completion Date:
October 2011
Related Keywords:
- Neoplasms
- Alopecia
- Alopecia
- Alopecia Areata
- Neoplasms