Efficacy of As-Needed Pilocarpine for the Treatment of Radiation-Induced Xerostomia: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study
Phase 3
Completed
- Conditions
- Radiation-induced xerostomia in patient with head and neck cancer underwent radiotherapyRadiation-induced xerostomia, xerostomia, head and neck cancer, radiotherapy, pilocarpine
- Registration Number
- TCTR20221130004
- Lead Sponsor
- Ratchadapisek Pageant Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Xerostomia Inventory Phase I: pre and post treatment, Phase II: pre and post treatment Xerostomia Inventory Questionnaire
- Secondary Outcome Measures
Name Time Method Adverse effects Everyday during phase I and II Patient reported adverse effects using a case record form