A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Proportion of subjects with a diagnosis of severe oral mucositis during the course of receiving up to 50 Gray (Gy) cumulative radiation dose administration with concurrent chemotherapy
研究概览
简要总结
Treatment for head and neck cancer often involves a combination of chemotherapy and radiation.
One of the unfortunate consequences of standard care for head and neck cancer is the development of painful mouth sores, known as oral mucositis.
This study will evaluate the use of cobiprostone spray to prevent oral mucositis, when given for the duration of radiation and chemotherapy (RT/CT) standard care.
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
- •Recently-diagnosed (within the last 6 months), histologically-documented, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality.
- •Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose administered via continuous course of external beam irradiation to the oral cavity and/or oropharynx via intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), combined with conventional or weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen.
排除标准
- •Subject has received prior radiation to the head and neck region (+/- chemotherapy).
- •Subject has had any other prior invasive malignancy, unless disease-free for a minimum of 3 years.
- •Subject has metastatic disease (M1) Stage IV-C.
- •Subject has a presence of mucosal ulceration or oral mucositis at screening or develops this prior to randomization, and/or has unhealed wounds remaining from surgical resection and/or excisional biopsy procedure.
- •Subject is using a pre-existing feeding tube for nutritional support at study entry.
研究组 & 干预措施
Cobiprostone 30 mcg four times daily
Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
干预措施: Cobiprostone (Drug)
Cobiprostone 30 mcg four times daily
Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
干预措施: Standard Care - Chemotherapy (Drug)
Cobiprostone 30 mcg four times daily
Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
干预措施: Standard Care - Radiation (Radiation)
Placebo 0 mcg four times daily
Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
干预措施: Placebo (Drug)
Placebo 0 mcg four times daily
Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
干预措施: Standard Care - Chemotherapy (Drug)
Placebo 0 mcg four times daily
Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
干预措施: Standard Care - Radiation (Radiation)
结局指标
主要结局
Proportion of subjects with a diagnosis of severe oral mucositis during the course of receiving up to 50 Gray (Gy) cumulative radiation dose administration with concurrent chemotherapy
时间窗: 50 Gray (Gy), up to 12 weeks
Overall mean Area Under the Curve (AUC) of oral mucositis severity over time
时间窗: 50 Gray (Gy), up to 12 weeks
次要结局
- Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)](50 Gray (Gy), up to 12 weeks)
- Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis(50 Gray (Gy), up to 12 weeks)
- Time-to-onset of severe [World Health Organization (WHO) grade 3 or 4] oral mucositis following initiation of RT/CT(50 Gray (Gy), up to 12 weeks)
- Mean cumulative radiation dose at time of severe (WHO grade 3 or 4) oral mucositis onset(50 Gray (Gy), up to 12 weeks)