Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients.
Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Daily treatment with light therapy will start at the beginning of the conditioning regimen and will last until day 21 post-transplant. Each daily treatment last about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a weekly basis.
详细描述
Primary endpoint:
o Assessment of effectiveness of treatment with QRay1 in preventing oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT).
Secondary endpoint:
- Assessment of mucositis associated- pain relief.
- Assessment of safety of treatment with QRay1 (oral adverse events).
- Assessment of the patients' acceptance of the device.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •No oral ulceration at baseline
- •At risk for oral mucositis due to the conditioning regimen to HSCT
- •Age above 18 years old
- •Karnofsky score >60
- •Agree to participate in the study (signed an informed consent)
排除标准
- •Pregnant woman
- •Well-founded doubt about the patient's jurisprudence
- •Sensitivity to light or treated with drugs which are sensitizers to light
- •Treatment with other experimental topical drug during the study period
研究组 & 干预措施
Active light therapy
oral mucosa is exposed to a light source (broad band of wavelengths, 400-800 nm)
干预措施: phototherapy (Device)
Inactive light therapy
Oral mucosa is exposed to a extremely low-intensity light which is assumed to have no effect.
干预措施: phototherapy (Device)