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Effect of Pilocarpine in Patients With Xerostomia

Primary Purpose

Xerostomia

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Pilocarpine

Spray without Pilocarpine

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Pilocarpine, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pilocarpine

Placebo

Arm Description

Spray with Pilocarpine

Spray without Pilocarpine

Outcomes

Primary Outcome Measures

Salivary flow

measured by stimulated salivation

Secondary Outcome Measures

Quality of life

measured by Oral Health Impact Profile (OHIP-14)

Xerostomia grade

measured by Xerostomia Inventory

Full Information

NCT ID

NCT02982577

First Posted

November 27, 2016

Last Updated

November 30, 2016

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02982577

Brief Title

Effect of Pilocarpine in Patients With Xerostomia

Official Title

Effect of Pilocarpine in Patients With Xerostomia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xerostomia

Keywords

Xerostomia, Pilocarpine, Quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pilocarpine

Arm Type

Experimental

Arm Description

Spray with Pilocarpine

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Spray without Pilocarpine

Intervention Type

Drug

Intervention Name(s)

Pilocarpine

Other Intervention Name(s)

Pilocarpine spray

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Spray without Pilocarpine

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Salivary flow

Description

measured by stimulated salivation

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

Secondary Outcome Measure Information:

Title

Quality of life

Description

measured by Oral Health Impact Profile (OHIP-14)

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

Title

Xerostomia grade

Description

measured by Xerostomia Inventory

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Raony MS Pereira, MSc

Phone

+55 16 981275221

raonymolimsp@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ana CF Motta, PhD

Phone

+55 16 33154067

anacfm@usp.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Camila Tirapelli, PhD

Organizational Affiliation

University of São Paulo

Official's Role

Study Director

Facility Information:

Facility Name

University of São Paulo

City

Ribeirao Preto

State/Province

São Paulo

ZIP/Postal Code

14040904

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raony MS Pereira, MSc

Phone

+55 16 981275221

raonymolimsp@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ana CF Motta, PhD

Phone

+55 16 33154067

anacfm@usp.br

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26436597

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.

Results Reference

background

PubMed Identifier

25322971

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.

Results Reference

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PubMed Identifier

24176001

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.

Results Reference

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PubMed Identifier

23346917

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.

Results Reference

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PubMed Identifier

27767109

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.

Results Reference

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PubMed Identifier

26867879

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.

Results Reference

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PubMed Identifier

26563850

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.

Results Reference

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PubMed Identifier

26001395

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.

Results Reference

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PubMed Identifier

25841622

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.

Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Effect of Pilocarpine in Patients With Xerostomia

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