An Adaptive Design, Single-Blind, Randomized, Controlled Study Investigating Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel (Gelclair®) in Comparison to Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash ("Magic Mouthwash") for the Management of Oral Mucositis Associated With High Dose Chemotherapy and Methotrexate in Allogeneic Stem Cell Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Incidence/occurrence of any grade Oral Mucositis
研究概览
简要总结
Patients receiving high-dose chemotherapy/conditioning prior to stem cell transplantation (SCT) are at high risk for developing painful lesions in the oral cavity, known as oral mucositis (OM).
In this high risk adult population, the study objectives are to investigate the efficacy and tolerability of Gelclair® (GEL; an FDA cleared medical device indicated for the management of painful oral lesions) and ideal timing of initiation of therapy (at the time of conditioning or after mild OM is diagnosed) for the management of oral mucositis (OM), relative to a commercially available compounded mouth wash (First® Mouthwash BLM "Magic Mouth Wash"; MMW) initiated after mild OM is diagnosed. The study may be adapted based on an interim analysis and recommendations of the interim data review committee.
详细描述
Adult patients at high risk for developing OM receiving one of the following myeloablative (MA) pre-transplant conditioning regimens prior to allogeneic transplant along with methotrexate (MTX) as part of graft vs. host disease (GVHD) prophylaxis meeting all other eligibility criteria will be enrolled:
- FluBu based regimens: either fludarabine: 30 mg/m^2 x 4 days and busulfan 0.8 mg/kg IV q6h x 4 days; both given daily starting at day -4 OR fludarabine: 40 mg/m^2 and busulfan: 3.2 mg/kg both given daily on days -6 through -3.
- Bu/Cy: busulfan, 0.8 mg/kg IV q6h x 4 days (-7 through -4); cyclophosphamide: 60 mg/kg IV once on days -3 and -2
- Cy/TBI: Cyclophosphamide, 60 mg/kg IV given twice between days -3 and -1 and TBI fractionated (generally over 3 days) for a total of 12Gy
GVHD Prophylaxis:
• Regimens including methotrexate (MTX; 15 mg/m^2 planned to be given on days 1, 3, 6 and 11); addition of other agents given along with MTX (e.g., tacrolimus, sirolimus) is acceptable.
Duration of treatment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
OM grading via the WHO oral toxicity grading scale will be performed by the trained blinded evaluator at least 3X/week (e.g., M, W and F), with ≤ 48h (±24h) in between each assessment.
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
- •Be age ≥ 18 years old.
- •Have Karnofsky performance status score ≥
- •Be scheduled to receive one of 3 myeloablative conditioning regimens (defined in population) followed by allogeneic SCT for hematological malignancy.
- •Have anticipated in-patient status for 14 to 20 days from the time of transplant.
- •Be willing and capable of swishing/gargling oral gel/solution as required per protocol.
- •Be willing and capable of completing the assessments and adhering to protocol requirements.
- •Be willing and able to provide written informed consent.
- •To be randomized to begin treatment, subjects randomized to Arms 2 or 3 must also meet the following criterion:
- •Be diagnosed with G1 or G2 OM via WHO OM scale during observation period from conditioning to Day +14.
排除标准
- •Subjects receiving pre-transplant conditioning/GVHD prophylaxis regimens other than those defined, herein.
- •Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day
- •Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral herpes or unexplained febrile illness (≥ 99.5F /37.5C) requiring systemic anti-infectives, within 7d of treatment Day
- •Subjects with active oral lesions or other mouth/throat soreness within 7d of study randomization.
- •Any other criteria, in the opinion of the investigator that would make the subject unsuitable for study participation.
- •For subjects randomized to Treatment Arms 2 or 3 during observation period:
- •OM ≥ G3 diagnosed prior to initiating randomized treatment during observation period (conditioning through Day +14; i.e., missed treatment window).
结局指标
主要结局
Incidence/occurrence of any grade Oral Mucositis
时间窗: Initial study period (initiation of conditioning through day +14 post-transplant)
Incidence/develop of any grade of OM as assessed via WHO OM grading scale (Grades possible: 1-4)
Area under the curve in mouth and throat soreness (MTS)
时间窗: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
次要结局
- Duration of severe OM(Study period (initiation of conditioning through day +28 post-transplant))
- Severity of OM(Study period (initiation of conditioning through day +28 post-transplant))
- Magnitude of OM-related pain control(While OM ongoing during study period (initiation of conditioning through day +28 post-transplant))
- Time to onset of any grade OM(Initial study period (initiation of conditioning through day +14 post-transplant))
- Duration of pain control(While OM ongoing during study period (initiation of conditioning through day +28 post-transplant))
- Time to onset of severe OM(Study period (initiation of conditioning through day +28 post-transplant))
- Duration of any grade OM(Study period (initiation of conditioning through day +28 post-transplant))
- Incidence of severe OM(Study period (initiation of conditioning through day +28 post-transplant))
- Opiate and other background pain medication use(While OM ongoing during study period (initiation of conditioning through day +28 post-transplant))