Effect of Pilocarpine in Patients With Xerostomia

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Pilocarpine

Criteria

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.