Effect of Pilocarpine in Patients With Xerostomia

NCT02982577 | Unknown Phase 4

• 1 other identifier: 27765714.0.0000.5419
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia

Keywords

Xerostomia; Pilocarpine; Quality of life

Outcome Measures

Primary Outcomes (1)

• Salivary flow

  measured by stimulated salivation

  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 (2)

• 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

• 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

Study Arms (2)

Pilocarpine

EXPERIMENTAL

Spray with Pilocarpine

Drug: Pilocarpine

Placebo

PLACEBO COMPARATOR

Spray without Pilocarpine

Other: Spray without Pilocarpine

Interventions

Pilocarpine DRUG

Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.

Also known as: Pilocarpine spray

Pilocarpine

Spray without Pilocarpine OTHER

Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14040904, Brazil

RECRUITING

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Xerostomia

Interventions

Pilocarpine

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Camila Tirapelli, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Central Study Contacts

Raony MS Pereira, MSc

CONTACT

+55 16 981275221; raonymolimsp@hotmail.com

Ana CF Motta, PhD

CONTACT

+55 16 33154067; anacfm@usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 5, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 5, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)