NCT01008774CompletedNot Applicable
A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 239
- Locations
- 1
- Primary Endpoint
- Grade III or IV alopecia according to the WHO criteria
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Experimental
Intervention: Paxman Cooling Machine (Device)
B
Active Comparator
Intervention: Cold Caps (Device)
C
No Intervention
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Study Sites (1)
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