START: Swiss Taxotere Alopecia Prevention Trial

A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia

Primary objective:

• Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)

Secondary objective:

• Compliance to scalp cooling procedure
• Received number of cycles of chemotherapy in each subgroup
• Patient perception of scalp cooling procedure
• Side effects of scalp cooling systems

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