Effect of Pilocarpine in Patients With Xerostomia

Phase 4

• Conditions: Xerostomia
• Interventions: Other: Spray without Pilocarpine; Drug: Pilocarpine

• Registration Number: NCT02982577
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-11
• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2016-11-30
• Last Update Submitted: 2016-11-30
• Study First Posted: 2016-12-05
• Last Update Posted: 2016-12-05
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Spray without Pilocarpine	Spray without Pilocarpine
Pilocarpine	Pilocarpine	Spray with Pilocarpine

Primary Outcome Measures

Name	Time	Method
Salivary flow	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

Secondary Outcome Measures

Name	Time	Method
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	measured by Oral Health Impact Profile (OHIP-14)
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	measured by Xerostomia Inventory

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 Ribeirao Preto, São Paulo, Brazil