Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)
- Conditions
- NauseaVomiting
- Interventions
- Radiation: Low or moderate risk radiotherapy
- Registration Number
- NCT02388750
- Lead Sponsor
- Dr. Edward Chow
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
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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.
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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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No previous nausea and vomiting Palonosetron Palonosetron 0.5 mg oral capsule given for the length of radiation treatment No previous nausea and vomiting 24 hours prior to radiotherapy No previous nausea and vomiting Low or moderate risk radiotherapy 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 Palonosetron Palonosetron 0.5 mg oral capsule given for the length of radiation treatment Previous nausea and/or vomiting 24 hours prior to radiotherapy Previous nausea and/or vomiting Low or moderate risk radiotherapy Palonosetron 0.5 mg oral capsule given for the length of radiation treatment Previous nausea and/or vomiting 24 hours prior to radiotherapy
- Primary Outcome Measures
Name Time Method Efficacy for prevention of nausea and vomiting events as measured by a daily diary Day 0 to Day 10 post-radiation 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.
- Secondary Outcome Measures
Name Time Method Complete prophylaxis of nausea Day 0 to Day 10 post-radiation 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
Complete prophylaxis of vomiting Day 0 to Day 10 post-radiation 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
Partial control of nausea Day 0 to Day 10 post-radiation Proportion of patients achieving partial control of nausea during and in the 10 days following radiation therapy
Partial control of vomiting Day 0 to Day 10 post-radiation Proportion of patients achieving partial control of vomiting during and in the 10 days following radiation therapy
Time to use of rescue medication Day 0 to Day 10 post-radiation Median time from first fraction of radiation therapy to first use or increase in use of rescue medication
Time to nausea Day 0 to Day 10 post-radiation Median time from first fraction of radiation therapy to first episode or increase in episodes of nausea
Time to vomiting Day 0 to Day 10 post-radiation Median time from first fraction of radiation therapy to first episode or increase in episodes of vomiting
Adverse effects Day 0 to Day 10 post-radiation The side effects of constipation and headache will be monitored throughout the study period graded according to the CTCAE criteria.
Quality of life Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation. Quality of life as measured by the EORTC QLQ-C15-PAL and the FLIE.
Trial Locations
- Locations (1)
Odette Cancer Centre, Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada