A Prospective Randomized Pilot Study Using Ice Chips Versus Room Temperature Normal Saline Rinses Orally During Administration of Melphalan to Decrease the Severity and Duration of Oral Mucositis in Patients With Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Chemoprotective agents may protect normal cells from the side effects of chemotherapy. Ice chips or saline mouth rinse may lessen the severity or help prevent symptoms of mucositis or mouth sores in patients receiving melphalan and autologous stem cell transplant for multiple myeloma. It is not yet known whether ice chips are more effective than saline mouth rinse in reducing or preventing mucositis.
PURPOSE: This randomized phase III trial is studying ice chips to see how well they work compared to saline mouth rinse in reducing or preventing mucositis in patients receiving melphalan and autologous stem cell transplant for multiple myeloma.
详细描述
OBJECTIVES:
- Compare the efficacy of administering ice chips vs room temperature normal saline oral rinse before, during, and after melphalan administration, in terms of reducing or eliminating grade 3 or 4 oral mucositis, in patients undergoing autologous peripheral blood stem cell transplantation (PBSCT) for multiple myeloma.
- Compare the number of days that IV narcotic therapy is required for oral mucositis pain in patients treated with these regimens.
- Compare the use of IV hydration and/or total parenteral nutrition after autologous PBSCT in patients treated with these regimens.
- Compare overall quality of life, in terms of ability to eat food and drink liquids, in patients treated with these regimens.
OUTLINE: This is a randomized, pilot study. Patients are stratified according to age (less than 60 years vs 60 years and over). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ice chips 15 minutes before, during, and for 8 hours after melphalan infusion* on day -2.
- Arm II: Patients receive room temperature normal saline oral rinses over 30 seconds 15 minutes before, during, and for 8 hours after melphalan infusion* on day -2.
All patients undergo autologous peripheral blood stem cell transplantation (PBSCT)* on day 0.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
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
- 未提供
排除标准
- 未提供
