Treatment and Prevention of Oral and Alimentary Mucositis Using Polymerized Cross-Linked High Potency Sucralfate as a Single Agent Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from Baseline in Oral Mucositis Assessment Score (OMAS) at Day 1, 2,4,7,14,21
研究概览
简要总结
RATIONALE: Polymerized (cross-linked) sucralfate malate paste (ProThelial) may be an effective single therapy approach for the management of chemoradiation mucositis, treating and preventing its occurrence in the oral cavity, esophagus, stomach, small and large intestine.
PURPOSE: This observational multi-phase trial is studying how well polymerized (cross-linked) sucralfate malate paste (ProThelial) works to prevent and treat mucositis in adult patients who are to receive or have received chemo/radiation therapy that have caused or is anticipated to cause mucositis in the oral cavity, esophagus, stomach, small or large intestine. The Phase IV study addresses prevention and treatment in the oral cavity. The Phase I study addresses prevention and treatment in the esophagus, stomach, small and large intestine.
详细描述
OBJECTIVES:
Primary
- Observe the incidence of mucositis in patients receiving ProThelial prior to developing chemoradiation mucositis in the oral cavity, esophagus, stomach, small or large intestine.
- Observe the change from baseline in symptoms & signs of mucositis in chemoradiation patients on Prothelial who have developed mucositis in the oral cavity, esophagus, stomach, small or large intestine.
Secondary
- Patient-reported quality of relief by ProThelial (treatment portion) Using Pain Visual Analogue Scale (PVAS) Using Difficulty Swallowing Visual Analogue Scale (DSVAS)
- To evaluate the safety and tolerability of ProThelial (Phase I non-oral uses)
- To observe the adverse event profile of ProThelial using patient-reported Questionnaire
- To observe effect on pain assessed day 1, 2,4,7,14,21 by Pain VAS
- To observe effect on oral ulcerations assessed day 1, 2,4,7,14,21 by OMAS
- To observe effect on symptoms of esophageal mucositis assessed day1, 2,4,7,14, 21using Difficulty Swallowing Visual Analogue Scale
- To observe effect on symptoms of gastric and small intestine mucositis assessed day 1,2,4,7,14,21 using the Nausea Visual Analogue Scale & the NCI GI Toxicity Scale for Nausea, Vomiting
- To observe effect on symptoms of large intestine mucositis assessed day 1,2,4,7,14,21 by NCI GI Toxicity Scale for Colonic Diarrhea
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Informed consent
- •Patients receiving cancer therapy with agents likely to cause mucositis
- •Patients who have developed mucositis from chemo/and or radiation
- •Patients to receive these that cause nausea, vomiting
- •Patients to receive these that cause diarrhea
- •Patients with Head & Neck cancer to receive chemo/radiation and G-Tube
- •Patients to undergo Hematopoietic Stem Cell Transplantation
排除标准
- •Absence of consent
- •Unable or unwilling to complete the self assessment questionnaire.
- •Use of any mouthwash out of study
- •Simultaneous treatment by an agent for prevention/treatment of mucositis
- •Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis
- •Have known allergies or intolerance to ProThelial or its ingredients (sucralfate)
结局指标
主要结局
Change from Baseline in Oral Mucositis Assessment Score (OMAS) at Day 1, 2,4,7,14,21
时间窗: Baseline, Day 1, 2,4,7,14,21
Measures are to report the change from baseline in the OMAS used to assess patient in the treatment of oral mucositis by ProThelial (Phase IV)
次要结局
- Change from baseline in difficulty swallowing as measured by Difficulty Swallowing Visual Analogue Scale (DSVAS) at Day 1, 2,4,7,14,21(Baseline, Day 1, 2,4,7,14, 21)
- Change from baseline in toxicity grade of mucositis as measured by NCI Toxicity Grade for Alimentary Mucositis at Day 1, 2,4,7,14,21(Baseline, Day 1, 2,4,7,14,21)
- Change from baseline in Pain as measured by Pain Visual Analogue Scale (PVAS) at Day1, 2,4,7,14, 21(Baseline, Day 1, 2, 4, 7,14,21)