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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilocarpine | Experimental | Spray with Pilocarpine |
|
| Placebo | Placebo Comparator | Spray without Pilocarpine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilocarpine | Drug | Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Xerostomia grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raony MS Pereira, MSc | Contact | +55 16 981275221 | raonymolimsp@hotmail.com | |
| Ana CF Motta, PhD | Contact | +55 16 33154067 | anacfm@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Camila Tirapelli, PhD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo | Recruiting | Ribeirão Preto | São Paulo | 14040904 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26436597 | Background | 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. | |
| 25322971 | 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. |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D010862 | Pilocarpine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Spray without Pilocarpine | Other | Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days. |
|
|
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 |
| 24176001 | 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. |
| 23346917 | 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. |
| 27767109 | Result | 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. |
| 26867879 | 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. |
| 26563850 | 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. |
| 26001395 | 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. |
| 25841622 | 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. |
| 25639487 | 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. |
| 25065774 | 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. |
| 24692737 | 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. |
| 24527846 | 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. |