The effect of stopping the H2-antagonist ranitidine in premedication regimens during paclitaxel treatment: ‘The RANISTOP study’

The effect of stopping the H2-antagonist ranitidine in premedication regimens during paclitaxel treatment.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24209

Enrollment

366

Registered

2019-10-25

Start date

2018-04-17

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy / anaphylaxis

Interventions

Removal of ranitidine from the paclitaxel premedication regimen

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactJuul Cox

Maasstad Ziekenhuis

coxj@maasstadziekenhuis.nl+31102911321

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)