NCT02388750

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

Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Dr. Edward Chow · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	Palonosetron	Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT
RADIATION	Low or moderate risk radiotherapy	Low or moderately emetogenic radiotherapy will be given to all patients on study.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-08-07
• Completion: 2017-08-07
• First posted: 2015-03-17
• Last updated: 2017-10-06

Locations

1 site across 1 country: Canada