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XerostomiaPhase 4NCT02982577

Effect of Pilocarpine in Patients With Xerostomia

A Phase 4 study testing Pilocarpine and Spray without Pilocarpine in people with Xerostomia, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Xerostomia
What is being tested?
Pilocarpine and Spray without Pilocarpine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteBrazil
Study dates
Apr 2016to Jul 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Sensitivity to pilocarpine
  • Secondary Sjögren's syndrome;
  • Type II diabetes mellitus;
  • AIDS;
  • pregnant or lactating women;
  • Glaucoma;
Show all 12Show fewer
  • Uncontrolled asthma;
  • Chronic obstructive pulmonary disease;
  • Renal diseases;
  • Severe cardiovascular diseases;
  • Gastrointestinal disorders;
  • Hepatic insufficiency.

Trial locations and contacts

1 site in 1 country.

Raony MS Pereira, MSc contact

+55 16 981275221

raonymolimsp@hotmail.com

Ana CF Motta, PhD contact

+55 16 33154067

anacfm@usp.br

Brazil1 site, 1 recruiting

  • University of São Paulo

    Ribeirão Preto, São Paulo, 14040904

    Raony MS Pereira, MSc, +55 16 981275221, raonymolimsp@hotmail.com

    Ana CF Motta, PhD, +55 16 33154067, anacfm@usp.br

    Recruiting

Other trials in Brazil

About this study

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.

Read the 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.

Conditions
Xerostomia
Being tested
Pilocarpine, Spray without Pilocarpine
Keywords
Xerostomia, Pilocarpine, Quality of life
Medical subject headings
Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PilocarpineDrug

    Also called Pilocarpine spray

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

  • Spray without PilocarpineOther

    Also called Placebo

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

Study groups in NCT02982577
Study groupRoleWhat they receive
PilocarpineExperimentalSpray with Pilocarpine
Receives: Drug: Pilocarpine
PlaceboPlacebo comparatorSpray without Pilocarpine
Receives: Other: Spray without Pilocarpine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary flow

    measured by stimulated salivation

    Measured: 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)

  1. Quality of life

    measured by Oral Health Impact Profile (OHIP-14)

    Measured: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures

  2. Xerostomia grade

    measured by Xerostomia Inventory

    Measured: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02982577
Sponsor's protocol ID
27765714.0.0000.5419
Status last verified
Nov 2016
First submitted
27 Nov 2016
Last updated
5 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26436597

  • 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.

    PubMed 25322971

  • 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.

    PubMed 24176001

  • 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.

    PubMed 23346917

  • 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.

    PubMed 27767109

  • 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.

    PubMed 26867879

  • 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.

    PubMed 26563850

  • 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.

    PubMed 26001395

  • 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.

    PubMed 25841622

  • 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.

    PubMed 25639487

  • 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.

    PubMed 25065774

  • 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.

    PubMed 24692737

  • 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.

    PubMed 24527846

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pilocarpine and Spray without Pilocarpine in people with Xerostomia, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Raony MS Pereira, MSc (+55 16 981275221, raonymolimsp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary flow (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02982577, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.

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