Effect of Pilocarpine in Patients With Xerostomia
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Salivary flow
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a spray the basis of pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto (HCFMRP-USP), and its impact on quality of life.
详细描述
There will be two groups: Group 1 (G1) - will use a spray with pilocarpine for three months and after a washout period of a month, use a spray without pilocarpine for another three months; Group 2 (G2) - will use a spray without pilocarpine for three months and after a washout period of a month, use a spray with pilocarpine for another three months (in a randomized, controlled, duble blind and crossover study). Participants will be submitted to OHIP-14, Xerostomia Inventory (XI) and salivary flow measurement before the start of therapy - baseline (T0), one (T2), two (T3) and three (T4) months after starting the use of spray, after washout, crossover occurs and the same parameters are measured for the same periods (T0', T2', T3' and T4'), and is measured one hour after the saliva (T1 and T1') baseline.
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
- Double (Participant, Investigator)
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
- •Age equal or superior to 18 years;
- •Both genders;
- •Lucid and without diagnosis of any psychiatric disorder;
- •Diagnosed with head and neck cancer and treated for a period of up to 5 years with radiotherapy where the major salivary glands (parotid, submandibular and sublingual) were included in the radiation field;
- •Primary Sjögren's syndrome with the diagnosis made by the American-European criteria.
排除标准
- •Sensitivity to pilocarpine
- •Secondary Sjögren's syndrome;
- •Type II diabetes mellitus;
- •pregnant or lactating women;
- •Glaucoma;
- •Uncontrolled asthma;
- •Chronic obstructive pulmonary disease;
- •Renal diseases;
- •Severe cardiovascular diseases;
- •Gastrointestinal disorders;
- •Hepatic insufficiency.
研究组 & 干预措施
Pilocarpine
Spray with Pilocarpine
干预措施: Pilocarpine (Drug)
Placebo
Spray without Pilocarpine
干预措施: Spray without Pilocarpine (Other)
结局指标
主要结局
Salivary flow
时间窗: baseline, 1 hour after baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
measured by stimulated salivation
次要结局
- Quality of life(baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures)
- Xerostomia grade(baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures)
研究者
Raony Môlim de Sousa Pereira
MSc
University of Sao Paulo