NL-OMON44353
Recruiting
Not Applicable
Prospective, multi-centre trial to evaluate effectiveness of 45-min and 20-min post-infusion cooling time for patients treated with scalp cooling to prevent paclitaxel-induced alopecia - COP
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cancer
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 90
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Patients receiving weekly\-administered paclitaxel\-containing chemotherapy (minimal of 3 planned administrations) in a dose of 80\-90 mg/m2
- •o Paclitaxel monotherapy
- •o Paclitaxel in combination with carboplatin
- •o Paclitaxel in combination with monoclonal antibodies:
- •\* Bevacizumab
- •\* Trastuzumab
- •\* Age \* 18 years
- •\* WHO performance status 0\-2
- •\* Survival expectation must be \> 3 months
- •\* Written informed consent according to the local Ethics Committee requirements
Exclusion Criteria
- •\* Treatment with paclitaxel in sequential schemes with other alopecia inducing agents such as (paclitaxel monotherapy after adriamycin, cyclophosphamide (AC) or paclitaxel monotherapy after 5\-fluouracil, epirubicin, cyclophosphamide (FEC) treatment)
- •\* Alopecia before the start of the study
- •\* Rare cold\-related disorders, like:
- •o Cold sensitivity
- •o Cold agglutinin disease
- •o Cryoglobulinaemia
- •o Cryofibrinogenaemia
- •o Cold posttraumatic dystrophy
Outcomes
Primary Outcomes
Not specified
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