Effect of Pilocarpine in Patients With Xerostomia

Xerostomia Clinical Trial

Official title:

Effect of Pilocarpine in Patients With Xerostomia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02982577
• Other study ID #: 27765714.0.0000.5419
• Status: Recruiting
• Phase: Phase 4
• First received: November 27, 2016
• Last updated: November 30, 2016
• Start date: April 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: University of Sao Paulo
• Contact: Raony MS Pereira, MSc
• Phone: +55 16 981275221
• Email: raonymolimsp[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Xerostomia

Intervention

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

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

Locations

Country	Name	City	State
Brazil	University of São Paulo	Ribeirao Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (13)

Brito-Zerón P, Sisó-Almirall A, Bové A, Kostov BA, Ramos-Casals M. Primary Sjögren 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. Review. — View 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/ — View Citation

Davies AN, Thompson J. Parasympathomimetic drugs for the treatment of salivary gland dysfunction due to radiotherapy. Cochrane Database Syst Rev. 2015 Oct 5;(10):CD003782. doi: 10.1002/14651858.CD003782.pub3. Review. — View 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. Review. — View 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. — View 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. — View 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: 10.1177/026 — View Citation

Noaiseh G, Baker JF, Vivino FB. Comparison of the discontinuation rates and side-effect profiles of pilocarpine and cevimeline for xerostomia in primary Sjögren's syndrome. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):575-7. — View Citation

Pimentel MJ, Filho MM, Araújo M, Gomes DQ, DA Costa LJ. Evaluation of radioprotective effect of pilocarpine ingestion on salivary glands. Anticancer Res. 2014 Apr;34(4):1993-9. — View 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. — View 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. — View Citation

Wong RK, Deshmukh S, Wyatt G, Sagar S, Singh AK, Sultanem K, Nguyen-Tân 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 — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of life	measured by Oral Health Impact Profile (OHIP-14)	baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures	No
Secondary	Xerostomia grade	measured by Xerostomia Inventory	baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures	No