Xerostomia in Patients With a Life-limiting Condition or Frailty: a Double-blind Placebo-controlled Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline.
研究概览
简要总结
Xerostomia, the subjective feeling of dry mouth, is a common symptom during the last year of life in patients with a life-limiting condition or frailty. Xerostomia leads to functional alterations (such as burning sensations, an altered taste perception, and difficulties with chewing, swallowing, and speaking), has disabling social consequences and significantly downgrades the perceived quality of life. It is an under-exposed and under-treated symptom often caused by alterations in the quality and quantity of saliva.
Locally administered pilocarpine could be a promising drug in this regard as it alleviates xerostomia by increasing the production of saliva.
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
- 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
- •have a life-limiting condition or frailty
- •have the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0= no dry mouth to 10= worst dry mouth ever)
- •fulfil the single SQ 'Would I be surprised if my patient dies within the year? (no)
排除标准
- •their life expectancy is less than 4 weeks (the primary endpoint at 4 weeks)
- •they have had radiotherapy to the salivary glands or suffer from Sjögrens disease (impact on dry mouth)
- •cognitively impaired to such an extent that there is insufficient understanding to complete questionnaires
研究组 & 干预措施
Treatment
干预措施: Pilocarpine (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline.
时间窗: 4 weeks
A patient counts as a responder with, at least, a 2-point reduction on the 11-point NRS
次要结局
- The adherence rate of patients(4 -12 weeks)
- Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group(4 - 12 weeks)
- Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group(4 - 12 weeks)
- Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group(4 - 12 weeks)
- Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group(4 - 12 weeks)
- Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group(4 - 12 weeks)
- The durability of the effect of the use of pilocarpine on xerostomia(4 - 12 weeks)
- Cost Effectiveness Analysis (CEA) of the pilocarpine treatment(4 - 12 weeks)
- Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group(4 - 12 weeks)