Effect of Pilocarpine in Patients With Xerostomia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Pilocarpine in Patients With Xerostomia

Conditions
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Xerostomia

Intervention / Treatment
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* Drug: Pilocarpine
* Other: Spray without Pilocarpine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Sensitivity to pilocarpine Secondary Sjögren's syndrome; Type II diabetes mellitus; AIDS; pregnant or lactating women; Glaucoma; Uncontrolled asthma; Chronic obstructive pulmonary disease; Renal diseases; Severe cardiovascular diseases; Gastrointestinal disorders; Hepatic insufficiency.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilocarpine<br>Spray with Pilocarpine | Drug: Pilocarpine<br>* Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.<br>* Other names: Pilocarpine spray;|
| Placebo Comparator: Placebo<br>Spray without Pilocarpine | Other: Spray without Pilocarpine<br>* Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary flow | measured by stimulated salivation | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | measured by Oral Health Impact Profile (OHIP-14) | 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 | measured by Xerostomia Inventory | baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerostomia, Pilocarpine, Quality of life