START: Swiss Taxotere Alopecia Prevention Trial

Sanofi

Status: Completed

Conditions: Alopecia; Neoplasms

Treatments: Device: Paxman Cooling Machine; Device: Cold Caps

Study type: Interventional

Funder types: Industry

Identifiers

NCT01008774

DOCET_L_04449

Details and patient eligibility

About

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

Enrollment: 239 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 3 patient groups

A

Experimental group

Treatment:

Device: Paxman Cooling Machine

B

Active Comparator group

Treatment:

Device: Cold Caps

C

No Intervention group