Evaluate the Effects of Aqualief® Mucoadhesive Tablets (a Food Supplement Based on Carnosine and Hibiscus) in Patients Who Developed Oral Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Saliva Production
研究概览
简要总结
The treatment of xerostomia is aimed to increase existing saliva flow or replace lost secretions, the control of the state of oral health, the control of dental caries, and the treatment of possible infections.
Therapy options in xerostomia depend on the presence of residual secretion or the absence of it. When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.
Aqualief® is a food supplement based on carnosine and hibiscus. These two ingredients are mixed in specific proportions to form a pH buffering system which maintains the pH of the oral cavity at the proper value which is required for the regular secretion of saliva.
详细描述
Xerostomia is the biggest and chronic side effect of the RT for head and neck cancer. To treat xerostomia different approach should be followed at the same time: to increase existing saliva flow or replace lost secretions, to control the state of oral health, to control dental caries and to treat possible infections18.
When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.
The salivary flow can be stimulated by the use of sugarless chewing gum or xylitol/sorbitol candy or through parasympathomimetic drug such as pilocarpine. Pilocarpine is a natural alkaloid that activates cholinergic receptors, authorized to treat xerostomia. Due to its main mechanism of action, pilocarpine has some muscarinic side effects19, especially vomiting, sweating, headache, increased urinary frequency, wheezing, watery eyes, nausea and gastrointestinal intolerance, hypotension, rhinitis, diarrhea, and visual disturbances. Pilocarpine has also some use restrictions that make it not prescribable to certain patients (patients with asthma, high blood pressure, heart diseases and in therapy with β-blockers cannot use pilocarpine because this drug is a nonselective antagonist of muscarinic receptors and, therefore, it can interfere with the cardiac and respiratory functions).
Acupuncture seems to alleviate radio-induced xerostomia but it mechanism of action is not totally clear and systematic reviews indicate its efficacy as doubtful20,21.
Other products are under investigation and their efficacy in xerostomia due to RT is still unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male and female which are 18 years of age or older
- •Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures
- •Subjects presenting:hyposalivation of grade 2 or greater (according to CTCAE scale vers. 4) and an objective, unstimulated salivary flow between 0.1 and 0.25 ml/min following radiation or radiation + systemic therapies with curative intent (definitive or postoperative), for tumors located in the head / neck region, completed from at least 6 months and free from cancer disease
- •Absence of infections in the oral cavity
- •Absence of antibiotics and antifungal treatments or any odontoiatric procedure in the 10 days before each treatment phase of the study.
排除标准
- •Contraindications in administration of carnosine and hibiscus
- •Known hypersensitivity to the components present in the product.
- •Subjects taking products or medications to reduce symptoms of salivary gland hypofunction (Pilocarpine etc.)
- •Patients with other underlying conditions that can cause xerostomia.
- •Use of experimental drugs within 30 days prior to enrollment or during the study.
- •Presence of clinical conditions that may interfere with the study evaluations.
- •Pregnant or lactating women.
结局指标
主要结局
Saliva Production
时间窗: Change from baseline to 8 days of treatment
Change of saliva production, without mechanical stimulation.
次要结局
- MD Anderson Dysphagia Inventory (MDADI) questionnaire(Change from baseline to 8 days of treatment)
- Adherence to the treatment by accountability(Total tablets used from baseline to 8 days of treatment)
- Patient's global satisfaction(from baseline to 8 days of treatment)
- pH of the mouth cavity evaluation(Change from baseline to 8 days of treatment)
- Xerostomia Evaluation (XQ-I questionnaire)(Change from baseline to 8 days of treatment)