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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study

Conditions
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Vomiting, Nausea

Intervention / Treatment
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* Drug: Palonosetron
* Radiation: Low or moderate risk radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

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 |
| --- | --- |
| Other: No previous nausea and vomiting<br>Palonosetron 0.5 mg oral capsule given for the length of radiation treatment No previous nausea and vomiting 24 hours prior to radiotherapy | Drug: Palonosetron<br>* Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT<br>Radiation: Low or moderate risk radiotherapy<br>* Low or moderately emetogenic radiotherapy will be given to all patients on study.<br>|
| Other: Previous nausea and/or vomiting<br>Palonosetron 0.5 mg oral capsule given for the length of radiation treatment Previous nausea and/or vomiting 24 hours prior to radiotherapy | Drug: Palonosetron<br>* Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT<br>Radiation: Low or moderate risk radiotherapy<br>* Low or moderately emetogenic radiotherapy will be given to all patients on study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy for prevention of nausea and vomiting events as measured by a daily diary | Primary outcome is to determine the efficacy of palonosetron for the prevention of radiation-induced vomiting in patients undergoing low or moderate emetogenic radiation therapy. Daily diary collects events of nausea and/or vomiting, and corresponding severity. | Day 0 to Day 10 post-radiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete prophylaxis of nausea | Proportion of patients achieving complete prophylaxis of nausea and not requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy | Day 0 to Day 10 post-radiation | 
| Complete prophylaxis of vomiting | Proportion of patients achieving complete prophylaxis of vomiting without requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy | Day 0 to Day 10 post-radiation | 
| Partial control of nausea | Proportion of patients achieving partial control of nausea during and in the 10 days following radiation therapy | Day 0 to Day 10 post-radiation | 
| Partial control of vomiting | Proportion of patients achieving partial control of vomiting during and in the 10 days following radiation therapy | Day 0 to Day 10 post-radiation | 
| Time to use of rescue medication | Median time from first fraction of radiation therapy to first use or increase in use of rescue medication | Day 0 to Day 10 post-radiation | 
| Time to nausea | Median time from first fraction of radiation therapy to first episode or increase in episodes of nausea | Day 0 to Day 10 post-radiation | 
| Time to vomiting | Median time from first fraction of radiation therapy to first episode or increase in episodes of vomiting | Day 0 to Day 10 post-radiation | 
| Quality of life | Quality of life as measured by the EORTC QLQ-C15-PAL and the FLIE. | Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation. | 
| Adverse effects | The side effects of constipation and headache will be monitored throughout the study period graded according to the CTCAE criteria. | Day 0 to Day 10 post-radiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, vomiting, radiation, anti-emetic drug