Back to resultsSTART: Swiss Taxotere Alopecia Prevention Trial
Primary Purpose
Neoplasms, Alopecia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Paxman Cooling Machine
Cold Caps
Sponsored by
About this trial
This is an interventional prevention trial for Neoplasms
Eligibility 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
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
A
B
C
Arm Description
Outcomes
Primary Outcome Measures
Grade III or IV alopecia according to the WHO criteria
Secondary Outcome Measures
Compliance to scalp cooling procedure
Side effects of scalp cooling systems
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01008774
Brief Title
START: Swiss Taxotere Alopecia Prevention Trial
Official Title
A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Alopecia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Paxman Cooling Machine
Intervention Description
Scalp cooling procedures
Intervention Type
Device
Intervention Name(s)
Cold Caps
Intervention Description
Scalp cooling procedures
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Compliance to scalp cooling procedure
Time Frame
D1 of each cycle and D+21 after last cycle of chemotherapy
Title
Side effects of scalp cooling systems
Time Frame
D1 of each cycle and D+21 after last cycle of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23636645
Citation
Betticher DC, Delmore G, Breitenstein U, Anchisi S, Zimmerli-Schwab B, Muller A, von Moos R, Hugli-Dayer AM, Schefer H, Bodenmann S, Buhler V, Trueb RR. Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Support Care Cancer. 2013 Sep;21(9):2565-73. doi: 10.1007/s00520-013-1804-9. Epub 2013 May 2.
Results Reference
derived
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START: Swiss Taxotere Alopecia Prevention Trial
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