Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation, a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 5
- 主要终点
- OM according to OMAS total during 28 days or until discharge
研究概览
简要总结
This study evaluates, among study patients with lymphoma or myeloma undergoing autologous SCT, whether cooling oral mucosa with a cooling device compared with ice cubes/crushed ice or ice pop succeeds in reducing the degree of oral mucositis (OM) according to the Oral Mucositis Assessment Scale (OMAS) total,degree of OM according to World Health Organisation (WHO), tolerability of either cooling method. The study is also aiming to , patients subjective experience of OM, rating of general quality of life and oral pain, number of days with total parenteral nutrition (TPN), number of hospital days, total dose of opioids, and C reactive protein during time in care.
Finally, the study aims to evaluate weight loss, Leukocyte particle concentration, number of days until bone marrow response, S-albumin, and body temperature.
详细描述
The degree of OM is assessed at eight intraoral locations, in accordance with the Oral Mucositis Assessment Scale (OMAS) (graded 0-3 for ulceration and 0-2 for erythema). 0 corresponds to "normal" while 3 and 2 are "sore >3 cm2" and "severe erythema" respectively. The assessment generates both an average for OMAS ulceration (0-3) and OMAS erythema (0-2) and a total average OMAS (0-5), which is the mean of both ulceration and erythema.
Besides OMAS, ulceration and erythema are also assessed with the WHO scale (graded 0-4) where 0 is "no mucositis" and 4 is "ulceration, total parenteral nutrition".
Assessment with OMAS and WHO is done by a dentist, blinded to treatment group, three times a week, for example, Monday, Wednesday, Friday, until discharge or at most day +28.Assessment with the WHO is also performed by nurses who are not blinded to the treatment group, three times a week.
Furthermore, the patients, after cooling ends, assess the tolerability of the respective cooling method with the aid of a questionnaire developed for the study. The questionnaire is intended to give some idea of any discomfort or side effects the patients feel as a result of the cooling method.
The patients assess their perception of oral problems daily with the aid of specific questions in a diary developed for the study. The questions are intended to give a picture of the effect of OM on the patient's general status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 16 and 99 years of age diagnosed with lymphoma or myeloma
- •Able to communicate in Swedish
- •Treated with bis-chloroethylnitrosourea, etoposide, cytarabine, and cyclophosphamide(BEAC) or bis-chloroethylnitrosourea, etoposide, cytarabine, and melphalan (BEAM) (lymphoma diagnosis), melphalan (myeloma diagnosis), before stem cell transplantation (SCT)
排除标准
- •Patients who do not understand oral and written information in Swedish.
结局指标
主要结局
OM according to OMAS total during 28 days or until discharge
时间窗: 28 days or until discharge
Assesment with OMAS is done by a dentist blinded to treatment group, three times a week during 28 days or until discharge. Assessment with the not blinded to the treatment group, three times a week during 28 days or until discharge.
次要结局
未报告次要终点