drugset / Trial / NCT02388750

Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)

NCT02388750

Phase 2 Completed 96 enrolled Dr. Edward Chow
Non-randomizedParallel-groupOpen-labelPrevention

Summary

This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis or rescue of single or multiple fraction radiation induced nausea and vomiting. This prospective study employs a parallel arm design, allowing for inclusion of patients with pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients receiving radiotherapy known to have a low or moderate emetogenic risk will receive every other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of rescue medication, and impact on quality of life will be monitored during and after radiation treatment completion.

Timeline

Start
2015-04
Primary completion
2017-08-07
Completion
2017-08-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Palonosetron Other / unclassified 0.5 mg Oral

Indications

No indication recorded.