Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study of Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting - a Phase II Study

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secondary prophylaxis<br>Patients already experiencing mild nausea/vomiting within 24 hours before radiotherapy. Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx. 608 hours later in the day (bid). For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment. | Drug: Ondansetron<br>* Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.<br>* Other names: Ondissolve;|
| Experimental: Primary prophylaxis<br>Patients experiencing no nausea and vomiting 24 hours before commencement of radiotherapy. Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx. 608 hours later in the day (bid). For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment. | Drug: Ondansetron<br>* Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.<br>* Other names: Ondissolve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | The primary objectives are to examine the efficacy 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. Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline. Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy. Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication. | Day 0 - Day 10 |