Clinical trial NCT02006056: Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting
Official title: Prospective Study of Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting - a Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea
Vomiting
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Takeda Canada, Inc.
First posted: 2013-12-09
Enrollment: 30
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: The primary objective of the study is to examine the efficacy of Ondissolve for the prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. The study population will be 30 patients seen in the RRRP at the Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8 hours later the same day. Patients undergoing multiple fraction radiation therapy will take Ondissolve on weekends or holidays in between treatment. Secondary objectives include to evaluate key secondary endpoints related to RINV, and to investigate the ease and length of administration of protocol medicine. We hypothesize that Ondissolve will be effective in the prophylaxis of RINV, and the ease of use and administration will provide an appropriate delivery method for those unable to tolerate the oral form of ondansetron.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Patient will receive palliative radiation therapy considered emetogenic for bone metastases.
* Group 1: At least mild nausea and/or at least mild vomiting as recorded in the Baseline Nausea and Vomiting Data Collection Sheet
* Group 2: Nausea and vomiting recorded as 'none' in the Baseline Nausea and Vomiting Data Collection Sheet

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 corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity within 48 hours of protocol RT.
* Patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity during or within 10 days following completion of protocol RT.
* 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 the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
timeFrame: Day 0 - Day 10
Secondary outcomes:
Other outcomes:
measure: The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
timeFrame: Day 0-5 during treatment
measure: The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
timeFrame: Day 6-10 of treatment
measure: Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
timeFrame: Day 3
measure: Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
timeFrame: Day 7
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: Edward Chow, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References: