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START: Swiss Taxotere Alopecia Prevention Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008774
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Neoplasms Alopecia Device: Paxman Cooling Machine Device: Cold Caps Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
Study Start Date : July 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A Device: Paxman Cooling Machine
Scalp cooling procedures

Active Comparator: B Device: Cold Caps
Scalp cooling procedures

No Intervention: C



Primary Outcome Measures :
  1. Grade III or IV alopecia according to the WHO criteria [ Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy ]

Secondary Outcome Measures :
  1. Compliance to scalp cooling procedure [ Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy ]
  2. Side effects of scalp cooling systems [ Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008774


Locations
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Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01008774    
Other Study ID Numbers: DOCET_L_04449
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical