Clinical trial NCT02388750: Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)
Official title: Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea
Vomiting
Keywords: nausea
vomiting
radiation
anti-emetic drug
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: Efficacy for prevention of nausea and vomiting events as measured by a daily diary
timeFrame: Day 0 to Day 10 post-radiation
Secondary outcomes:
measure: Complete prophylaxis of nausea
timeFrame: Day 0 to Day 10 post-radiation
measure: Complete prophylaxis of vomiting
timeFrame: Day 0 to Day 10 post-radiation
measure: Partial control of nausea
timeFrame: Day 0 to Day 10 post-radiation
measure: Partial control of vomiting
timeFrame: Day 0 to Day 10 post-radiation
measure: Time to use of rescue medication
timeFrame: Day 0 to Day 10 post-radiation
measure: Time to nausea
timeFrame: Day 0 to Day 10 post-radiation
measure: Time to vomiting
timeFrame: Day 0 to Day 10 post-radiation
measure: Quality of life
timeFrame: Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation.
measure: Adverse effects
timeFrame: Day 0 to Day 10 post-radiation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre, Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre
name: Chow Edward, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References: