<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02982577</url>
  </required_header>
  <id_info>
    <org_study_id>27765714.0.0000.5419</org_study_id>
    <nct_id>NCT02982577</nct_id>
  </id_info>
  <brief_title>Effect of Pilocarpine in Patients With Xerostomia</brief_title>
  <official_title>Effect of Pilocarpine in Patients With Xerostomia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of a spray the basis of&#xD;
      pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary&#xD;
      Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto&#xD;
      (HCFMRP-USP), and its impact on quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There will be two groups: Group 1 (G1) - will use a spray with pilocarpine for three months&#xD;
      and after a washout period of a month, use a spray without pilocarpine for another three&#xD;
      months; Group 2 (G2) - will use a spray without pilocarpine for three months and after a&#xD;
      washout period of a month, use a spray with pilocarpine for another three months (in a&#xD;
      randomized, controlled, duble blind and crossover study). Participants will be submitted to&#xD;
      OHIP-14, Xerostomia Inventory (XI) and salivary flow measurement before the start of therapy&#xD;
      - baseline (T0), one (T2), two (T3) and three (T4) months after starting the use of spray,&#xD;
      after washout, crossover occurs and the same parameters are measured for the same periods&#xD;
      (T0', T2', T3' and T4'), and is measured one hour after the saliva (T1 and T1') baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Salivary flow</measure>
    <time_frame>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</time_frame>
    <description>measured by stimulated salivation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures</time_frame>
    <description>measured by Oral Health Impact Profile (OHIP-14)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Xerostomia grade</measure>
    <time_frame>baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures</time_frame>
    <description>measured by Xerostomia Inventory</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Xerostomia</condition>
  <arm_group>
    <arm_group_label>Pilocarpine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spray with Pilocarpine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Spray without Pilocarpine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pilocarpine</intervention_name>
    <description>Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.</description>
    <arm_group_label>Pilocarpine</arm_group_label>
    <other_name>Pilocarpine spray</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spray without Pilocarpine</intervention_name>
    <description>Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age equal or superior to 18 years;&#xD;
&#xD;
          -  Both genders;&#xD;
&#xD;
          -  Lucid and without diagnosis of any psychiatric disorder;&#xD;
&#xD;
          -  Diagnosed with head and neck cancer and treated for a period of up to 5 years with&#xD;
             radiotherapy where the major salivary glands (parotid, submandibular and sublingual)&#xD;
             were included in the radiation field;&#xD;
&#xD;
          -  Primary Sjögren's syndrome with the diagnosis made by the American-European criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sensitivity to pilocarpine&#xD;
&#xD;
          -  Secondary Sjögren's syndrome;&#xD;
&#xD;
          -  Type II diabetes mellitus;&#xD;
&#xD;
          -  AIDS;&#xD;
&#xD;
          -  pregnant or lactating women;&#xD;
&#xD;
          -  Glaucoma;&#xD;
&#xD;
          -  Uncontrolled asthma;&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease;&#xD;
&#xD;
          -  Renal diseases;&#xD;
&#xD;
          -  Severe cardiovascular diseases;&#xD;
&#xD;
          -  Gastrointestinal disorders;&#xD;
&#xD;
          -  Hepatic insufficiency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Camila Tirapelli, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raony MS Pereira, MSc</last_name>
    <phone>+55 16 981275221</phone>
    <email>raonymolimsp@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ana CF Motta, PhD</last_name>
    <phone>+55 16 33154067</phone>
    <email>anacfm@usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of São Paulo</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>São Paulo</state>
        <zip>14040904</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raony MS Pereira, MSc</last_name>
      <phone>+55 16 981275221</phone>
      <email>raonymolimsp@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ana CF Motta, PhD</last_name>
      <phone>+55 16 33154067</phone>
      <email>anacfm@usp.br</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Davies AN, Thompson J. Parasympathomimetic drugs for the treatment of salivary gland dysfunction due to radiotherapy. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD003782. doi: 10.1002/14651858.CD003782.pub3.</citation>
    <PMID>26436597</PMID>
  </reference>
  <reference>
    <citation>Hanchanale S, Adkinson L, Daniel S, Fleming M, Oxberry SG. Systematic literature review: xerostomia in advanced cancer patients. Support Care Cancer. 2015 Mar;23(3):881-8. doi: 10.1007/s00520-014-2477-8. Epub 2014 Oct 18.</citation>
    <PMID>25322971</PMID>
  </reference>
  <reference>
    <citation>Nikles J, Mitchell GK, Hardy J, Agar M, Senior H, Carmont SA, Schluter PJ, Good P, Vora R, Currow D. Do pilocarpine drops help dry mouth in palliative care patients: a protocol for an aggregated series of n-of-1 trials. BMC Palliat Care. 2013 Oct 31;12(1):39. doi: 10.1186/1472-684X-12-39.</citation>
    <PMID>24176001</PMID>
  </reference>
  <reference>
    <citation>Brito-Zeron P, Siso-Almirall A, Bove A, Kostov BA, Ramos-Casals M. Primary Sjogren syndrome: an update on current pharmacotherapy options and future directions. Expert Opin Pharmacother. 2013 Feb;14(3):279-89. doi: 10.1517/14656566.2013.767333. Epub 2013 Jan 25.</citation>
    <PMID>23346917</PMID>
  </reference>
  <results_reference>
    <citation>Spivakovsky S, Spivakovsky Y. Parasympathomimetic drugs for dry mouth due to radiotherapy. Evid Based Dent. 2016 Sep;17(3):79. doi: 10.1038/sj.ebd.6401185.</citation>
    <PMID>27767109</PMID>
  </results_reference>
  <results_reference>
    <citation>Yang WF, Liao GQ, Hakim SG, Ouyang DQ, Ringash J, Su YX. Is Pilocarpine Effective in Preventing Radiation-Induced Xerostomia? A Systematic Review and Meta-analysis. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):503-11. doi: 10.1016/j.ijrobp.2015.11.012. Epub 2015 Nov 10.</citation>
    <PMID>26867879</PMID>
  </results_reference>
  <results_reference>
    <citation>Cheng CQ, Xu H, Liu L, Wang RN, Liu YT, Li J, Zhou XK. Efficacy and safety of pilocarpine for radiation-induced xerostomia in patients with head and neck cancer: A systematic review and meta-analysis. J Am Dent Assoc. 2016 Apr;147(4):236-43. doi: 10.1016/j.adaj.2015.09.014. Epub 2015 Nov 10.</citation>
    <PMID>26563850</PMID>
  </results_reference>
  <results_reference>
    <citation>Nikles J, Mitchell GK, Hardy J, Agar M, Senior H, Carmont SA, Schluter PJ, Good P, Vora R, Currow D. Testing pilocarpine drops for dry mouth in advanced cancer using n-of-1 trials: A feasibility study. Palliat Med. 2015 Dec;29(10):967-74. doi: 10.1177/0269216315585473. Epub 2015 May 22.</citation>
    <PMID>26001395</PMID>
  </results_reference>
  <results_reference>
    <citation>Wong RK, Deshmukh S, Wyatt G, Sagar S, Singh AK, Sultanem K, Nguyen-Tan PF, Yom SS, Cardinale J, Yao M, Hodson I, Matthiesen CL, Suh J, Thakrar H, Pugh SL, Berk L. Acupuncture-Like Transcutaneous Electrical Nerve Stimulation Versus Pilocarpine in Treating Radiation-Induced Xerostomia: Results of RTOG 0537 Phase 3 Study. Int J Radiat Oncol Biol Phys. 2015 Jun 1;92(2):220-7. doi: 10.1016/j.ijrobp.2015.01.050. Epub 2015 Apr 1.</citation>
    <PMID>25841622</PMID>
  </results_reference>
  <results_reference>
    <citation>Tanigawa T, Yamashita J, Sato T, Shinohara A, Shibata R, Ueda H, Sasaki H. Efficacy and safety of pilocarpine mouthwash in elderly patients with xerostomia. Spec Care Dentist. 2015 Jul-Aug;35(4):164-9. doi: 10.1111/scd.12105. Epub 2015 Feb 2.</citation>
    <PMID>25639487</PMID>
  </results_reference>
  <results_reference>
    <citation>Noaiseh G, Baker JF, Vivino FB. Comparison of the discontinuation rates and side-effect profiles of pilocarpine and cevimeline for xerostomia in primary Sjogren's syndrome. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):575-7. Epub 2014 Jul 23.</citation>
    <PMID>25065774</PMID>
  </results_reference>
  <results_reference>
    <citation>Pimentel MJ, Filho MM, Araujo M, Gomes DQ, DA Costa LJ. Evaluation of radioprotective effect of pilocarpine ingestion on salivary glands. Anticancer Res. 2014 Apr;34(4):1993-9.</citation>
    <PMID>24692737</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim JH, Ahn HJ, Choi JH, Jung DW, Kwon JS. Effect of 0.1% pilocarpine mouthwash on xerostomia: double-blind, randomised controlled trial. J Oral Rehabil. 2014 Mar;41(3):226-35. doi: 10.1111/joor.12127. Epub 2013 Dec 30.</citation>
    <PMID>24527846</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Raony Môlim de Sousa Pereira</investigator_full_name>
    <investigator_title>MSc</investigator_title>
  </responsible_party>
  <keyword>Xerostomia</keyword>
  <keyword>Pilocarpine</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Xerostomia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pilocarpine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02982577
org study id: 27765714.0.0000.5419
nct id: NCT02982577
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Salivary flow
time frame: 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
description: measured by stimulated salivation
measure: Quality of life
time frame: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
description: measured by Oral Health Impact Profile (OHIP-14)
measure: Xerostomia grade
time frame: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
description: measured by Xerostomia Inventory
arm group label: Pilocarpine
arm group type: Experimental
description: Spray with Pilocarpine
arm group label: Placebo
arm group type: Placebo Comparator
description: Spray without Pilocarpine
intervention type: Drug
intervention name: Pilocarpine
description: Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.
arm group label: Pilocarpine
other name: Pilocarpine spray
intervention type: Other
intervention name: Spray without Pilocarpine
description: Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Camila Tirapelli, PhD
role: Study Director
affiliation: University of São Paulo
last name: Raony MS Pereira, MSc
phone: +55 16 981275221
email: raonymolimsp@hotmail.com
last name: Ana CF Motta, PhD
phone: +55 16 33154067
email: anacfm@usp.br
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
citation: Davies AN, Thompson J. Parasympathomimetic drugs for the treatment of salivary gland dysfunction due to radiotherapy. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD003782. doi: 10.1002/14651858.CD003782.pub3.
PMID: 26436597
citation: Hanchanale S, Adkinson L, Daniel S, Fleming M, Oxberry SG. Systematic literature review: xerostomia in advanced cancer patients. Support Care Cancer. 2015 Mar;23(3):881-8. doi: 10.1007/s00520-014-2477-8. Epub 2014 Oct 18.
PMID: 25322971
citation: Nikles J, Mitchell GK, Hardy J, Agar M, Senior H, Carmont SA, Schluter PJ, Good P, Vora R, Currow D. Do pilocarpine drops help dry mouth in palliative care patients: a protocol for an aggregated series of n-of-1 trials. BMC Palliat Care. 2013 Oct 31;12(1):39. doi: 10.1186/1472-684X-12-39.
PMID: 24176001
citation: Brito-Zeron P, Siso-Almirall A, Bove A, Kostov BA, Ramos-Casals M. Primary Sjogren syndrome: an update on current pharmacotherapy options and future directions. Expert Opin Pharmacother. 2013 Feb;14(3):279-89. doi: 10.1517/14656566.2013.767333. Epub 2013 Jan 25.
PMID: 23346917
citation: Spivakovsky S, Spivakovsky Y. Parasympathomimetic drugs for dry mouth due to radiotherapy. Evid Based Dent. 2016 Sep;17(3):79. doi: 10.1038/sj.ebd.6401185.
PMID: 27767109
citation: Yang WF, Liao GQ, Hakim SG, Ouyang DQ, Ringash J, Su YX. Is Pilocarpine Effective in Preventing Radiation-Induced Xerostomia? A Systematic Review and Meta-analysis. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):503-11. doi: 10.1016/j.ijrobp.2015.11.012. Epub 2015 Nov 10.
PMID: 26867879
citation: Cheng CQ, Xu H, Liu L, Wang RN, Liu YT, Li J, Zhou XK. Efficacy and safety of pilocarpine for radiation-induced xerostomia in patients with head and neck cancer: A systematic review and meta-analysis. J Am Dent Assoc. 2016 Apr;147(4):236-43. doi: 10.1016/j.adaj.2015.09.014. Epub 2015 Nov 10.
PMID: 26563850
citation: Nikles J, Mitchell GK, Hardy J, Agar M, Senior H, Carmont SA, Schluter PJ, Good P, Vora R, Currow D. Testing pilocarpine drops for dry mouth in advanced cancer using n-of-1 trials: A feasibility study. Palliat Med. 2015 Dec;29(10):967-74. doi: 10.1177/0269216315585473. Epub 2015 May 22.
PMID: 26001395
citation: Wong RK, Deshmukh S, Wyatt G, Sagar S, Singh AK, Sultanem K, Nguyen-Tan PF, Yom SS, Cardinale J, Yao M, Hodson I, Matthiesen CL, Suh J, Thakrar H, Pugh SL, Berk L. Acupuncture-Like Transcutaneous Electrical Nerve Stimulation Versus Pilocarpine in Treating Radiation-Induced Xerostomia: Results of RTOG 0537 Phase 3 Study. Int J Radiat Oncol Biol Phys. 2015 Jun 1;92(2):220-7. doi: 10.1016/j.ijrobp.2015.01.050. Epub 2015 Apr 1.
PMID: 25841622
citation: Tanigawa T, Yamashita J, Sato T, Shinohara A, Shibata R, Ueda H, Sasaki H. Efficacy and safety of pilocarpine mouthwash in elderly patients with xerostomia. Spec Care Dentist. 2015 Jul-Aug;35(4):164-9. doi: 10.1111/scd.12105. Epub 2015 Feb 2.
PMID: 25639487
citation: Noaiseh G, Baker JF, Vivino FB. Comparison of the discontinuation rates and side-effect profiles of pilocarpine and cevimeline for xerostomia in primary Sjogren's syndrome. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):575-7. Epub 2014 Jul 23.
PMID: 25065774
citation: Pimentel MJ, Filho MM, Araujo M, Gomes DQ, DA Costa LJ. Evaluation of radioprotective effect of pilocarpine ingestion on salivary glands. Anticancer Res. 2014 Apr;34(4):1993-9.
PMID: 24692737
citation: Kim JH, Ahn HJ, Choi JH, Jung DW, Kwon JS. Effect of 0.1% pilocarpine mouthwash on xerostomia: double-blind, randomised controlled trial. J Oral Rehabil. 2014 Mar;41(3):226-35. doi: 10.1111/joor.12127. Epub 2013 Dec 30.
PMID: 24527846
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Raony Môlim de Sousa Pereira
investigator title: MSc
mesh term: Xerostomia
mesh term: Pilocarpine
sharing ipd: No