Sicurezza ed Efficacia di un Prodotto a Base di Propoli (FARINGEL PLUS) Nella Prevenzione e Nel Trattamento Della Mucosite Orale in Pazienti in Cure Palliative: Uno Studio di Fase 2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Severity of oral mucositis
研究概览
简要总结
Oral health is crucial for palliative patients' quality of life. The evidence on effective interventions and measures of oral mucositis in palliative care is sparse.
This is a single-center, prospective, uncontrolled open label Phase 2 non-profit study, aimed at evaluating a propolis-based product (FARINGEL PLUS) added to basic oral hygiene safety, acceptability and activity in preventing and treating oral mucositis in patients in palliative care.
A two-step design was adopted according to Simon's Optimum approach, with an overall sample of 77 evaluable cases (step1_26 cases; step2_51 cases).
详细描述
Palliative Care with has primary objective of the best possible quality of life for patients with advanced illness. Oral health is crucial for quality of life. Oral disorders such as hyposalivation, mucositis, erythema, ulceration and viral and fungal infections, can cause annoying symptoms such as dry mouth, dysphagia, dysgeusia, orofacial pain and speech difficulties, which negatively affect nutrition, verbal communication, social interaction and sleep. An Italian study of advanced cancer patients in palliative care found a prevalence of oral mucositis of 22%, of dysphagia of 15% and of dry mouth of 40%.
Studies on interventions aimed at preventing and treating oral mucositis in palliative care are scarse and no standard oral protocol can be recommended.
Moreover, there are no known scales specifically developed and validated for the evaluation of mucositis and other disorders of the oral cavity in palliative care.
Propolis has historically been used as folk medicine due to multiple biological properties, such as anesthetic, antimicrobial, antifungal, antiviral, and anti-inflammatory for the oral and pharyngeal mucosa. Propolis is effective in reducing the severity of radiation-induced oral mucositis in animals, is associated with a significant reduction in the number and size of oral ulcers in patients diagnosed with recurrent stomatitis and with complete recovery from denture-related stomatitis, and is found safe, acceptable and with promising efficacy in preventing oral mucositis in patients undergoing chemotherapy for breast cancer.
In particular, an oral suspension based on propolis (Faringel) and containing aloe vera gel, calendula, chamomile and sodium alginate, has been found to be well accepted, safe and promising in the prevention of severe oesophagitis from radiotherapy in patients with lung cancer. Hyaluronic acid (Faringel plus) has recently been added to this suspension with a re-epithelizing function on the mucous membranes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients cared for by specialized palliative care center in hospice or at home
- •Conscious patients able to swallow (score 1-2 at the swallowing item of OAG)
- •Patients with a life expectancy of between one week and one month estimated with the RAD (Approximation of Death Recognition) card in use in the palliative care center where the study will be conducted;
- •Patients who provide consent to participate in the study and use the data independently, or through their legal representative.
排除标准
- •Patients with a life expectancy of less than one week or more than one month estimated with the RAD (Approximation of Death Recognition) card;
- •Patients who are unable to swallow (score 3 on the swallowing item on the OAG scale)
- •Patients with head / neck cancer or tracheostomy;
- •Patients who report allergy to propolis, honey, aloe, chamomile, calendula, stevia (or other components of the product under study) or atopy.
结局指标
主要结局
Severity of oral mucositis
时间窗: daily up to 15 days
Reduction of the severity of mucositis by at least one degree, or maintenance of the normal condition, measured by the elements of the OAG scale whose score indicates 3 degrees (from 1 normal condition to 3 severe mucositis). The minimum grade achieved during the patient's stay in the study will be considered.
次要结局
- Adherence to intervention(daily up to 15 days)
- dysgeusia(daily up to 15 days)
- Comfort during feeding(daily up to 15 days)
- orpharyngeal pain(daily up to 15 days)
- esophageal pain(daily up to 15 days)
- ability to swallow, voice condition, feeling of dry mouth(daily up to 15 days)
- Meal completion rate(daily up to 15 days)
- Patient oral-related quality of life(Daily up to 15 days)
- Oral fungal infections(daily up to 15 days)
- Patient quality of life(Every 3 days up to 15 days)
- Duration of oral disorders(daily up to 15 days)
研究者
Michela Piredda
Associate Professor
Campus Bio-Medico University