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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No previous nausea and vomiting | Other | Palonosetron 0.5 mg oral capsule given for the length of radiation treatment No previous nausea and vomiting 24 hours prior to radiotherapy |
|
| Previous nausea and/or vomiting | Other | Palonosetron 0.5 mg oral capsule given for the length of radiation treatment Previous nausea and/or vomiting 24 hours prior to radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron | Drug | Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chow Edward, MBBS PhD | Odette Cancer Centre, Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odette Cancer Centre, Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N3M5 | Canada |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
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| Low or moderate risk radiotherapy | Radiation | Low or moderately emetogenic radiotherapy will be given to all patients on study. |
|
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 |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |