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Clinical Trials/ACTRN12613000646741
ACTRN12613000646741
Not yet recruiting
Phase 2

PREPaRE study. A pilot study of corticosteroid and antihistamine premedication to prevent hypersensitivity reactions in patients receiving second (or subsequent) line treatment with Carboplatin for treatment of gynaecological malignancy

The Royal Women's Hospital0 sites46 target enrollmentJune 7, 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
hypersensitivity reactions in patients receiving carboplatin for gynaecological malignancy
Sponsor
The Royal Women's Hospital
Enrollment
46
Status
Not yet recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 7, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
The Royal Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18 years and above
  • Histologically confirmed gynaecological malignancy
  • Commencing a carboplatin\-containing regimen (this may include other chemo agents)
  • At least 1 prior line of carboplatin containing therapy
  • Performance status less than or equal to 2
  • Neutrophil count greater than or equal to 1\.5 x 109/L, Platelet count greater than or equal to 100 x 109/L
  • Ability to record symptoms in patient diary
  • Written informed consent

Exclusion Criteria

  • History of platinum HSR
  • Uncontrolled concurrent illness
  • Diabetes Mellitus requiring insulin
  • Pregnancy / lactation

Outcomes

Primary Outcomes

Not specified

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