Randomized Controlled, Open-Label Study on the Use of Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Number of participants that tolerate cryotherapy during each etoposide infusion
研究概览
简要总结
Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to treat the cancer. A number of treatment factors have been shown to influence the incidence and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy before stem cell transplantation can cause severe oral mucositis and is often the side effect that patients find the most difficult to endure. Cryotherapy, keeping ice chips in the mouth during chemotherapy infusion, has been shown to prevent or alleviate mucositis caused by high-dose melphalan alone or given in combinations used in pre-transplant conditioning. One other drug notorious for causing severe mucositis is etoposide (VP-16). The specific aims of the study are: 1) to assess tolerability of cryotherapy given during chemotherapy administration; 2) to determine the efficacy of cryotherapy in reducing etoposide-induced mucositis.
详细描述
As a participant the following will happen:
There will be a random assignment (much like the flip of a coin) to one of two study groups:
- Group A: Standard mouth care plus cryotherapy, or
- Group B: Standard mouth care.
Standard Mouth Care plus Cryotherapy (Group A)
Will receive the standard mouth care plus Cryotherapy and will consist of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects age 18 year old or older who are eligible candidates for myeloablative autologous stem cell transplantation (ASCT).
- •Subjects receiving etoposide as part of their conditioning regimen with a planned total dose of ≥ 30 mg/kg.
排除标准
- •Subjects with prior radiation to head & neck region.
- •Subjects with known oropharynx involvement with their malignancy.
- •Subjects with a history of non-compliance or who lack capacity to give informed consent.
研究组 & 干预措施
Cryotherapy Group (Group A)
Subjects in the intervention group will receive both standard oral care and cryotherapy. During the 30 minute cryotherapy periods, subjects will eat ice chips, and/or consume very cold or frozen foods. Cryotherapy will begin 15 minutes prior to the start time of each etoposide infusion. After 30 minutes of cryotherapy, subjects will begin the saline rinses. The subject should perform 3 saline rinses over 15 minutes. After 15 minutes of saline rinses, the 30-minute cryotherapy / 15-minute saline rinse cycles will be repeated until 30 min after completion of etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators.
干预措施: Ice (Other)
Standard Oral Care Group (Group B)
Subjects in the control group will receive standard oral care only. At the beginning of each etoposide infusion, the subject will begin the saline rinses. The subject will perform 3 saline rinses over 15 minutes followed by 30 minutes of rest (no rinses). The 15-minute saline rinse / 30-minute rest cycles will be repeated until 30 minutes after the completion of the etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators.
干预措施: Normal Saline Solution (Other)
结局指标
主要结局
Number of participants that tolerate cryotherapy during each etoposide infusion
时间窗: Up to seven days prior to stem cell transplant.
Time to onset, severity and duration of mucositis following etoposide administration
时间窗: Participants will be followed starting on Day +1 post-transplant until they are discharged from the hospital, an expected average of 3-4 weeks.
次要结局
未报告次要终点