NCT01941992已完成2 期
Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period.
研究概览
简要总结
The purpose of this study is to:
- evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.
- assess tolerability of SAMITAL and the impact on patients reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Histologically proven squamous cell carcinomas of the head-and-neck
- •Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
- •Stage III or IV disease without evidence of distant metastases
- •Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
- •Age ≥ 18 years
- •Karnofsky Performance Status ≥70
- •Life expectancy ≥6 months
- •Able to swallow and retain oral medication
- •Good state of dentition
- •Patients must be available for treatment and follow-up
- •Confirmation of adequate contraception use by the patient and/or partner
- •Signed informed consent
排除标准
- •Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
- •Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
- •Chronic administration of steroids or immunosuppressants
- •Pregnancy.
研究组 & 干预措施
SAMITAL® sachets, oral suspension
Experimental
SAMITAL® sachets for oral suspension, 20 mL, four times a day.
干预措施: SAMITAL® (Drug)
Placebo sachets
Placebo Comparator
Placebo sachets for oral suspension, 20 mL, four times a day.
干预措施: Placebo sachets (Drug)
结局指标
主要结局
Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period.
时间窗: Within 19 weeks after starting Radiotherapy
次要结局
- Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0)(Within 19 weeks after starting Radiotherapy)
研究者
研究点 (1)
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