A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Subjective xerostomia
研究概览
简要总结
This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient.
详细描述
Background:
A majority of patients in palliative care have problems with dry mouth caused by medication or as a direct result of the mortal condition. Dry mouth will cause a variety of problems that commonly affect the disease negatively and contribute to reduced quality of life in the patient's last stage of life. A Cochrane review from 2011 concludes that "there are several moisturising agents available, but no strong evidence that any topical therapy is effective for relieving the symptom of dry mouth." It also concludes that "Oxygenated glycerol triester (OGT) oral spray is more effective than an aqueous electrolyte spray."1
Objectives:
To compare the effectiveness of 3 different oral moisturisers, ; 17 % watery solution of glycerol, OGT oral spray, Aequasyal® and a newly developed product, Salient®.
Methods/design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A Block randomisation is made by a person, other than the one who applies the product. Neither the patient nor the person who records the product or the person who registers data knows which product is used for the intervention. The product is not labeled with name
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients have xerostomia (subjective feeling of dry mouth). 2
- •The patients are palliative and in institutionalized care.
- •Curative treatment of existing diseases has been completed.
- •WHOs functional status 3/Karnofsky functional status 30 - 40 % (only capable of limited self-care, tied to bed or chair more than 50% of wake time).
- •Participants are cognitively functioning, capable of and willing to consent, capable of giving responses to a limited questionnaire and are expected to remain at the care centre for a minimum of 3 days.
排除标准
- •Patients treated with radiotherapy in head and neck region.
研究组 & 干预措施
Glycerol 17 %
Oral moisturizer
干预措施: Glycerol 17% (Device)
Aequasyal (OGT)
Oral moisturizer
干预措施: Aequasyal (OGT) (Device)
Salient (new product)
Oral moisturizer
干预措施: Salient (new product) (Device)
结局指标
主要结局
Subjective xerostomia
时间窗: 3 days
Measured on a 5-point Likert-scale: Subjective feeling of dry mouth: 1. Not dry 2. Insignificantly dry 3. Fairly dry 4. Almost completely dry 5. Completely dry
次要结局
- Speech(3 days)
- Pain/discomfort(3 days)
- Diurnal variation(3 days)
- Situational dry mouth(3 days)