START: Swiss Taxotere Alopecia Prevention Trial

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008774
• Other study ID #: DOCET_L_04449
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: January 20, 2012
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Neoplasms

Intervention

Device:
• Paxman Cooling Machine
Scalp cooling procedures
• Cold Caps
Scalp cooling procedures

Locations

Country	Name	City	State
Switzerland	Sanofi-Aventis Administrative Office	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade III or IV alopecia according to the WHO criteria		D1 of each cycle and D+21 after last cycle of chemotherapy	No
Secondary	Compliance to scalp cooling procedure		D1 of each cycle and D+21 after last cycle of chemotherapy	No
Secondary	Side effects of scalp cooling systems		D1 of each cycle and D+21 after last cycle of chemotherapy	No