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START: Swiss Taxotere Alopecia Prevention Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01008774
First received: October 1, 2009
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

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

Condition Intervention
Neoplasms
Alopecia
 Device: Paxman Cooling Machine
Device: Cold Caps

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Grade III or IV alopecia according to the WHO criteria [ Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance to scalp cooling procedure [ Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy ] [ Designated as safety issue: No ]
  • Side effects of scalp cooling systems [ Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: July 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Paxman Cooling Machine
Scalp cooling procedures
Active Comparator: B Device: Cold Caps
Scalp cooling procedures
No Intervention: C

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008774

Locations
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01008774     History of Changes
Other Study ID Numbers: DOCET_L_04449
Study First Received: October 1, 2009
Last Updated: January 20, 2012
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Neoplasms
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013