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Clinical Trials/NL-OMON44353
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

eids Universitair Medisch Centrum0 sites90 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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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