None listed
Conditions
Brief summary
The study is evaluating whether premedication can prevent or delay the onset of carboplatin hypersensitivity reactions in women win gynaecological malignancy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a gynaecological malignancy, for which you will be commencing a carboplatin containing chemotherapy regime. Eligible patients will have already undergone at least one prior line of carboplatin containing therapy. Trial details All participants in this study will be given premedication with Dexamethasone, Loratadine and Ranitidine the night before chemotherapy, the morning of chemotherapy and about 30 minutes prior to chemotherapy. These will be administered orally (by mouth) the night before and the morning of chemotherapy, and intravenously (directly into the vein) about 30 minutes prior to chemotherapy. All participants will be asked to complete a symptom diary, and will be clinically assessed in order to evaluate whether the study premedication can prevent or delay the onset of hypersensitivity reactions following chemotherapy with carboplatin. If it does (compared to a control group who receive their care in the past), then a subsequent larger randomised trial will be developed.
Interventions
All participants will be given the following premedication. The night before chemo (at least 12 hours prior to carboplatin): Dexamethasone 20mg orally, Loratadine 10mg orally and Ranitidine 150mg orally.
Morning of chemo (at least 2 hours prior to carboplatin):Dexamethasone 20mg orally, loratadine 10mg orally
In chemo suite (at least 30 mins prior to carboplatin): Dexamethasone 20mg intravenously, ranitidine 50mg intravenously, ondansetron 8mg intravenously (unless contraindicated)
Patients wi
All participants will be given the following premedication. The night before chemo (at least 12 hours prior to carboplatin): Dexamethasone 20mg orally, Loratadine 10mg orally and Ranitidine 150mg orally. Morning of chemo (at least 2 hours prior to carboplatin):Dexamethasone 20mg orally, loratadine 10mg orally In chemo suite (at least 30 mins prior to carboplatin): Dexamethasone 20mg intravenously, ranitidine 50mg intravenously, ondansetron 8mg intravenously (unless contraindicated) Patients will be asked about adherence with the premedications on the patient questionnaire completed prior to all chemotherapy. All patients will be given the same premedication regime prior to all chemotherapy sessions.
Sponsors
The Royal Women's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed