Overview

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

Status:
Completed
Trial end date:
2017-08-07
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dr. Edward Chow
Treatments:
Palonosetron
Criteria
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) emetogenic
palliative radiotherapy.

- Patients will be grouped according to nausea and vomiting status at baseline as
follows:

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

- Group 2: Patient is experiencing at least mild nausea and/or at least mild
vomiting at baseline

Exclusion Criteria:

- Patient is scheduled to receive cranial radiation therapy during or within 10 days
following 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 following
completion of protocol RT.

- Patient received moderately or highly emetogenic chemotherapy within 7 days prior to
commencement of protocol RT.

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

- Patient is scheduled to change regimen/dose or start the use of low dose
corticosteroids (inhaled or topical permitted), or other medications considered to
have antiemetic properties during or within 10 days following completion of protocol
RT.

- Concurrent use of corticosteroids during protocol RT is not permitted, unless low dose
corticosteroids (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 using
contraceptive measures.