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

Last updated: October 5, 2017
Sponsor: Dr. Edward Chow
Overall Status: Completed

Phase

2

Condition

Colic

Lactose Intolerance

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT02388750
Palonosetron
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent

  • Patient will receive radiation therapy to considered moderate risk (upper abdomen,upper and half body irradiation) or low risk (lower thorax and pelvis) emetogenicpalliative radiotherapy.

  • Patients will be grouped according to nausea and vomiting status at baseline asfollows:

  • Group 1: Patient is experiencing no nausea and vomiting at baseline

  • Group 2: Patient is experiencing at least mild nausea and/or at least mildvomiting at baseline

Exclusion

Exclusion Criteria:

  • Patient is scheduled to receive cranial radiation therapy during or within 10 daysfollowing completion of protocol RT.

  • Patient received cranial RT within 7 days prior to commencement of protocol RT.

  • Patient is scheduled to receive chemotherapy during or within 10 days followingcompletion of protocol RT.

  • Patient received moderately or highly emetogenic chemotherapy within 7 days prior tocommencement of protocol RT.

  • Patient is scheduled to change regimen/dose or start the use of low dosecorticosteroids (inhaled or topical permitted), or other medications considered tohave antiemetic properties within 48 hours prior to protocol RT.

  • Patient is scheduled to change regimen/dose or start the use of low dosecorticosteroids (inhaled or topical permitted), or other medications considered tohave antiemetic properties during or within 10 days following completion of protocolRT.

  • Concurrent use of corticosteroids during protocol RT is not permitted, unless low dosecorticosteroids (hydrocortisone) are used for cancer treatment

  • Patient is allergic to protocol medication.

  • Patient has a Karnofsky Performance Status score <40.

  • Patient is a woman who is pregnant or of childbearing potential and is not usingcontraceptive measures.

Study Design

Total Participants: 96
Study Start date:
April 01, 2015
Estimated Completion Date:
August 07, 2017

Connect with a study center

  • Odette Cancer Centre, Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N3M5
    Canada

    Site Not Available

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