Alopecia, Neoplasms
Conditions
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
Interventions
DEVICEPaxman Cooling Machine
Scalp cooling procedures
DEVICECold Caps
Scalp cooling procedures
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade III or IV alopecia according to the WHO criteria | D1 of each cycle and D+21 after last cycle of chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed