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Efficacy of As-Needed Pilocarpine for the Treatment of Radiation-Induced Xerostomia: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study

Efficacy of As-Needed Pilocarpine for the Treatment of Radiation-Induced Xerostomia: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221130004
Enrollment
20
Registered
2022-11-30
Start date
2022-06-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation-induced xerostomia in patient with head and neck cancer underwent radiotherapy Radiation-induced xerostomia, xerostomia, head and neck cancer, radiotherapy, pilocarpine

Interventions

During phase I of the trial, pilocarpine 5 mg tablets (in sealed envelop) will be given to the patient for a total of 42 tablets. The patient will be instructed to take the medication in as needed dos

Sponsors

Ratchadapisek Pageant Research Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years old and above 2. Diagnosed with head and neck cancer 3. Underwent radiotherapy (IMRT or 3D-CRT technique) more than 6 months prior to entering this study 4. History of xerostomia 5. Clinical Oral Dryness Score 3 and above 6. Can understand Thai 7. Able to attend follow-up visits 8. Consent to be in the study

Exclusion criteria

Exclusion criteria: 1. Pilocarpine allergy 2.Autoimmune disease 3.Patient with current medications affecting salivary flows 4. Patient with swallowing proble or currently using nasogastric tube feeding 5.Patient with current use of pilocarpine or other sialogogue within 1 month prior to the study 6. Pregnant woman and lactating woman 7. Patient underwent oral surgery and salivary gland surgery

Design outcomes

Primary

MeasureTime frame
Xerostomia Inventory Phase I: pre and post treatment, Phase II: pre and post treatment Xerostomia Inventory Questionnaire

Secondary

MeasureTime frame
Adverse effects Everyday during phase I and II Patient reported adverse effects using a case record form

Countries

Thailand

Contacts

Public ContactNatcha Watapokasin

Faculty of Medicine, Chulalongkorn University

6575397630@student.chula.ac.th02 256 4000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026