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Effect of Pilocarpine in Patients With Xerostomia

NCT ID: NCT02982577

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Xerostomia

Keywords

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Xerostomia Pilocarpine Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pilocarpine

Spray with Pilocarpine

Group Type EXPERIMENTAL

Pilocarpine

Intervention Type DRUG

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

Placebo

Spray without Pilocarpine

Group Type PLACEBO_COMPARATOR

Spray without Pilocarpine

Intervention Type OTHER

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

Interventions

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Pilocarpine

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

Intervention Type DRUG

Spray without Pilocarpine

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

Intervention Type OTHER

Other Intervention Names

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Pilocarpine spray Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Raony Môlim de Sousa Pereira

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camila Tirapelli, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Raony MS Pereira, MSc

Role: CONTACT

Phone: +55 16 981275221

Email: [email protected]

Ana CF Motta, PhD

Role: CONTACT

Phone: +55 16 33154067

Email: [email protected]

Facility Contacts

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Raony MS Pereira, MSc

Role: primary

Ana CF Motta, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26436597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25322971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24176001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23346917 (View on PubMed)

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.

Reference Type RESULT
PMID: 27767109 (View on PubMed)

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.

Reference Type RESULT
PMID: 26867879 (View on PubMed)

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.

Reference Type RESULT
PMID: 26563850 (View on PubMed)

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.

Reference Type RESULT
PMID: 26001395 (View on PubMed)

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.

Reference Type RESULT
PMID: 25841622 (View on PubMed)

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.

Reference Type RESULT
PMID: 25639487 (View on PubMed)

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.

Reference Type RESULT
PMID: 25065774 (View on PubMed)

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.

Reference Type RESULT
PMID: 24692737 (View on PubMed)

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.

Reference Type RESULT
PMID: 24527846 (View on PubMed)

Other Identifiers

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27765714.0.0000.5419

Identifier Type: -

Identifier Source: org_study_id