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

NCT02388750 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-10-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Dr. Edward Chow

    lead OTHER

Principal Investigators

  • Chow Edward, MBBS PhD · Odette Cancer Centre, Sunnybrook Health Sciences Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-08-07
Completion
2017-08-07

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388750 on ClinicalTrials.gov