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Effect of Pilocarpine in Patients With Xerostomia

Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT02982577
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
15
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Pilocarpine in Patients With Xerostomia
Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pilocarpine

Spray with Pilocarpine

Drug: Pilocarpine
Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.
Other Names:
  • Pilocarpine spray

    		•
    Placebo Comparator: Placebo

    Spray without Pilocarpine

    Other: Spray without Pilocarpine
    Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of São Paulo Ribeirao Preto São Paulo Brazil 14040904

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    • Study Director: Camila Tirapelli, PhD, University of São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Raony Môlim de Sousa Pereira, MSc, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02982577
    Other Study ID Numbers:
    • 27765714.0.0000.5419
    First Posted:
    Dec 5, 2016
    Last Update Posted:
    Dec 5, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Raony Môlim de Sousa Pereira, MSc, University of Sao Paulo
    Xerostomia
    Pilocarpine
    Quality of life
    Additional relevant MeSH terms:
    Xerostomia
    Pilocarpine

    Study Results

    No Results Posted as of Dec 5, 2016