A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of severe Oral Mucositis
研究概览
简要总结
This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device.
The name of the study device involved in this study is:
- THOR LX2.3 with LED Lollipop
详细描述
As part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of alloHCT as well as immunosuppressive medications to help prevent graft-versus-host disease ("GVHD prophylaxis"). Together, these treatments will put patients at risk for developing side effects. A common side effect is oral mucositis (OM), in which mouth sores develop making eating and speaking difficult and painful.
Photobiomodulation therapy (PBMT) is a light-based therapy that reduces inflammation and enhances wound healing. PBMT delivered inside the mouth has been shown to reduce OM in patients undergoing alloHCT.
The name of the study device involved in this study is:
- THOR LX2.3 with LED Lollipop
This research study is a Pilot Study, which is the first time that investigators are examining this LED based intraoral PBMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis.
- •Age ≥18 years.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT.
- •Participants who have a history of radiation therapy to the head and neck.
- •Participants who have a history of photosensitivity or underlying disease with known photosensitivity.
- •Participants who are planned to receive palifermin for OM prevention.
研究组 & 干预措施
INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT
The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive the study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first
-THOR LX2.3 with LED Lollipop
干预措施: THOR LX2.3 with LED Lollipop (Device)
结局指标
主要结局
Duration of severe Oral Mucositis
时间窗: 20 Days
Defined as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported
次要结局
未报告次要终点
研究者
Kentaro Ikeda, DDS, MPH
Principal Investigator
Dana-Farber Cancer Institute