A Phase 3, Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- NCI v3 to measure severity of OM
研究概览
简要总结
Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).
详细描述
This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years and older
- •newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT.
- •Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx
- •Chemotherapy: cisplatin
- •Have a WBC ≥3500 per cubic millimeter
- •Have a platelet count ≥100,000 per cubic millimeter
- •Have adequate renal function as determined by the principal investigator prior to enrollment
- •Are willing and able to undergo oral assessments
- •Have a Karnofsky Performance Status score ≥70
- •Significant
排除标准
- •Have OM or other oral conditions at study entry
- •Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol
- •Are using a pre-existing feeding tube for nutritional support at study entry
- •Plan to use any drug for the treatment or prevention of OM
- •Have had any prior radiotherapy to the head and neck
- •Have had prior chemotherapy within 6 months preceding enrollment
- •Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria
- •Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
- •Have medical conditions that require the use of chronic steroid therapy
- •Have the inability to undergo repeat treatments,
研究组 & 干预措施
EN3285 (NAC ProGelz)
The EN3285 arm is the product under development
干预措施: EN3285 (Drug)
No active ingredients (placebo)
This will be an oral product that contains no active ingredient
干预措施: Placebo (Drug)
Standard of Care
This arm will reflect the typical standard of care for the patient
干预措施: Standard of care (Other)
结局指标
主要结局
NCI v3 to measure severity of OM
时间窗: At 50 Gy
次要结局
- WHO criteria for measuring severity of OM(At 50 Gy)