NCT01149642已完成不适用
Phase III Multicenter, Randomised and Double-blind Study Comparing an Oral Immunomodulatory Solution Versus a Placebo in Preventing Severe Acute Mucositis in Head and Neck Cancer Patients Treated Surgically and Concomitantly With Radiochemotherapy
Institut du Cancer de Montpellier - Val d'Aurelle2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The rate of grade 3 and 4 acute mucosal toxicity
研究概览
简要总结
This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epidermal carcinoma proven histologically of the sphere ORL (all locations except nasopharynx).
- •Patients with tumours of the oral cavity, the oropharynx, the hypopharynx and the larynx treated initially by surgery and eligible for post-operative radio- chemotherapy concomitantly.
- •NB. The patients with tumours of the larynx or hypopharynx are eligible if the radiotherapy to the oropharyngeal mucosa will be at least 54 Gy and the mucositis can be visualised without the use of instruments.
- •Radio-chemotherapy to be given postoperatively.
- •Maximum delay of 8 weeks between the operative date and the planned starting date of radio-chemotherapy.
- •Performance status (grade OMS): 0, 1, 2
- •Nutritional Risk Index ≥ 83.5
- •No mucositis.
- •Age: 18-75 years
- •Life expectancy ≥ 3 months.
- •Informed consent obtained from the patient.
- •Affiliation with a social security system.
排除标准
- •Tumour of nasopharynx
- •Mucositis
- •Severe sepsis
- •Treatment by immunomodulators in the month preceding inclusion
- •ATCD allergy to the components of Oral Impact.
- •Parenteral nutrition at inclusion
- •Usual contraindications to concomitant radio-chemotherapy
- •Patient already included in another therapeutic trial involving an experimental molecule
- •Female pregnant or susceptible to being pregnant, or breast-feeding. Patient not using appropriate contraceptive measures during the treatment
- •Persons deprived of liberty or under guardianship
- •Patients unable to commit to the trial schedule for geographical, social or psychological reasons.
结局指标
主要结局
The rate of grade 3 and 4 acute mucosal toxicity
时间窗: 3 months
次要结局
- Tolerance(through study completion, an average of 3 years)
- compliance to the oral immunomodulating formula(through study completion, an average of 3 years)
- overall quality of life (EORTC QLQ-C30 Questionnaire)(through study completion, an average of 3 years)
- progression-free survival rates(1, 2 and 3 years)
- overall survival rates(1, 2 and 3 years)
研究者
研究点 (2)
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