Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Efficacy for prevention of nausea and vomiting events as measured by a daily diary
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 <
- •Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.
研究组 & 干预措施
No previous nausea and vomiting
Palonosetron 0.5 mg oral capsule given for the length of radiation treatment
No previous nausea and vomiting 24 hours prior to radiotherapy
干预措施: Palonosetron (Drug)
No previous nausea and vomiting
Palonosetron 0.5 mg oral capsule given for the length of radiation treatment
No previous nausea and vomiting 24 hours prior to radiotherapy
干预措施: Low or moderate risk radiotherapy (Radiation)
Previous nausea and/or vomiting
Palonosetron 0.5 mg oral capsule given for the length of radiation treatment
Previous nausea and/or vomiting 24 hours prior to radiotherapy
干预措施: Palonosetron (Drug)
Previous nausea and/or vomiting
Palonosetron 0.5 mg oral capsule given for the length of radiation treatment
Previous nausea and/or vomiting 24 hours prior to radiotherapy
干预措施: Low or moderate risk radiotherapy (Radiation)
结局指标
主要结局
Efficacy for prevention of nausea and vomiting events as measured by a daily diary
时间窗: 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.
次要结局
- Complete prophylaxis of nausea(Day 0 to Day 10 post-radiation)
- Complete prophylaxis of vomiting(Day 0 to Day 10 post-radiation)
- Partial control of nausea(Day 0 to Day 10 post-radiation)
- Partial control of vomiting(Day 0 to Day 10 post-radiation)
- Time to use of rescue medication(Day 0 to Day 10 post-radiation)
- Time to nausea(Day 0 to Day 10 post-radiation)
- Time to vomiting(Day 0 to Day 10 post-radiation)
- Adverse effects(Day 0 to Day 10 post-radiation)
- Quality of life(Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation.)
研究者
Dr. Edward Chow
Professor
Sunnybrook Health Sciences Centre