A Randomized Controlled Study Evaluating the Effect of MUCIPLIQ Versus Placebo on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering of Upper Aerodigestive Tract Carcinomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 5
- 主要终点
- Incidence of grade 2 or higher oral mucositis
研究概览
简要总结
MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy.
The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent.
The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.
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
- •Patient suffering from an upper aerodigestive tract carcinoma treated by radiotherapy alone or radiotherapy associated with a concomitant platine-salts-based chemotherapy ;
- •Patient suffering of an upper aerodigestive tract carcinoma without entrance or located in the oral cavity, in the oropharynx or in the rhinopharynx ;
- •Patient age of 18 years old or higher ;
- •Writing informed consent to participate to the trial ;
- •Patient affiliated to the French social security system.
排除标准
- •Treatment by non-standard fragmentation (concentrate irradiation)
- •Carcinoma located in the hypopharynx or in the larynx ;
- •Known hypersensitivity to heparinoids ;
- •Patient who already benefited from a radiotherapy treatment ;
- •Patient who already benefited from a chemotherapy treatment. Patients who benefited from neoadjuvant chemotherapy as part of their upper aerodigestive tract carcinoma care, may be included if it was held at least 4 weeks before the inclusion visit ;
- •Patient participating to another biomedical research ;
- •Pregnant woman, breastfeeding woman, parturient or likely to be ;
- •Patient deprived of freedom, under supervision or guardianship ;
- •Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons
研究组 & 干预措施
Placebo
This arm receives a placebo (saline solution) mouthwash treatment twice a day.
干预措施: Placebo (Device)
MUCIPLIQ 0.05 mg/mL
This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day.
干预措施: MUCIPLIQ (Device)
MUCIPLIQ 0.015 mg/mL
This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day.
干预措施: MUCIPLIQ (Device)
结局指标
主要结局
Incidence of grade 2 or higher oral mucositis
时间窗: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Differences of incidence of patients suffering of oral mucositis of grade 2 or higher
次要结局
- Weight curve(Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks)
- Pain experienced in time(Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks)
- Assessment of the Oral Health Impact Profile(Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks)
- Number and Terms of grade 2 or higher oral mucositis(Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks)
- Administered-antalgics posology and nature(Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks)