Clinical trial NCT02982577: Effect of Pilocarpine in Patients With Xerostomia
Official title: Effect of Pilocarpine in Patients With Xerostomia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Xerostomia
Keywords: Xerostomia
Pilocarpine
Quality of life
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Salivary flow
timeFrame: 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 outcomes:
measure: Quality of life
timeFrame: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
measure: Xerostomia grade
timeFrame: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: University of São Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Camila Tirapelli, PhD
role: STUDY_DIRECTOR
References:
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