START: Swiss Taxotere Alopecia Prevention Trial

Not Applicable

Completed

• Conditions: Neoplasms; Alopecia
• Interventions: Device: Paxman Cooling Machine; Device: Cold Caps

• Registration Number: NCT01008774
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Paxman Cooling Machine	-
B	Cold Caps	-

Primary Outcome Measures

Name	Time	Method
Grade III or IV alopecia according to the WHO criteria	D1 of each cycle and D+21 after last cycle of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Side effects of scalp cooling systems	D1 of each cycle and D+21 after last cycle of chemotherapy
Compliance to scalp cooling procedure	D1 of each cycle and D+21 after last cycle of chemotherapy

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇭 Geneva, Switzerland