The effect of stopping the H2-antagonist ranitidine in premedication regimens during paclitaxel treatment: ‘The RANISTOP study’
Recruiting
- Conditions
- Allergy / anaphylaxis
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 366
Inclusion Criteria
In order to be eligible to participate in this study, a patient must meet the following criteria:
- Age =18 years;
- Planned treatment with regular paclitaxel based chemotherapy for any indication and with any dose.
Exclusion Criteria
A potential participant who meets any of the following criteria will be excluded in this study:
- Prior treatment with a paclitaxel-based regimen;nal reflux and ulcer disease.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be the percentage (%) of patients who experience an HSR CTCAE grade 3, 4 or 5 caused by paclitaxel infusion, grade determined prospectively by the oncology medical staff.
- Secondary Outcome Measures
Name Time Method Secondary outcome parameters will be the severity of the HSR, grades as defined by CTCAE (version 4.0); the number of paclitaxel dosages (n) until first HSR occurrence and the cumulative dose of paclitaxel (mg/m2) at the moment of HSR occurrence.