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

Phase 2

• Conditions: hypersensitivity reactions in patients receiving carboplatin for gynaecological malignancy; Cancer - Ovarian and primary peritoneal; Cancer - Womb (Uterine or endometrial cancer)

• Registration Number: ACTRN12613000646741
• Lead Sponsor: The Royal Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To document the incidence of carboplatin hypersensitivity reactions (HSR) in a population of patients receiving the defined premedication with second (or subsequent) line carboplatin for gynaecological malignancy. HSR will be documented using a HSR form where the investigator documents any symptoms occuring during or immediately after the carboplatin infusion and the patient records any symptoms occuring after discharge from the chemotherapy suite in a diary. [HSR symptoms will be recorded at the following time points for each cycle of chemotherapy with carboplatin:<br>1)Symptoms of acute HSR (i.e. HSR occurring during or immediately after carboplatin infusion) <br>2)Symptoms of delayed HSR (i.e. those occurring after discharge from chemotherapy suite) ]