Randomized Clinical Trial of a Ginger and Cardamom Gelatin Compared to a Camomile and Lemon Juice Infusion in Control of Xerostomy in Terminally Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Scale of self-perceived mouth dryness (0=not at all, 10=very dry)
研究概览
简要总结
Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your mouth. It's a frequent symptom in terminally ill patients receiving palliative care, reducing their quality of life and comfort. Usual recommendations in these patients are good oral hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions, and ad libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple). Other xerostomia treatments such as artificial saliva and pharmacological drugs (e.g. pilocarpine) are less used in terminally ill patients due to cost and secondary effects.
The purpose of this randomized parallel clinical trial is to determine if a new recipe of gelatin with orange juice, cardamome and ginger is more effective in the control of xerostomia than the usual treatment of camomile infusion with lemon juice against. Treatments will be consumed ad libitum during one week. The main outcome is the subjective assessment of dry mouth at end of treatment.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Receiving palliative care for terminall illness at MUTUAM PADES
- •Complaining of dry mouth and should not have been treated for this problem
- •Able to prepare the study supplemental products by himself/herself or having a personal carer willing to do so
排除标准
- •Disease of oral mucosa (e.g. oral mycosis, coated oral cavity ).
- •Oropharinx neoplasm treated with surgery or radiotherapy.
- •Severe cognitive impairment (More than 7 errors in Pfeiffer scale)
- •Motor dysphagia causing coordination problems in swallowing.
- •Life expectancy less than seven days (Last Days Situation).
结局指标
主要结局
Scale of self-perceived mouth dryness (0=not at all, 10=very dry)
时间窗: At end of treatment (1 week )
次要结局
- Objective signs of xerostomia(At end of treatment (1 week ))
- Scale of subjective assessment of salival disfunction (Pai 2001).(At end of treatment (1 week ))
- Treatment acceptability(At end of treatment (1 week ))
研究者
Teresa Peris
Palliativa Care Nurse
Mutuam
