Radiation-induced xerostomia Head and neck cancer Xerostomia,Pilocarpine,Head and neck cancer,Radiation therapy,Salivary gland dysfunction,Randomized controlled trial
Conditions
Interventions
Pilocarpine HCl 5 mg orally twice daily (BID) for 12 weeks during radiotherapy in patients with head and neck cancer,Orally administered inert tablet identical in appearance to pilocarpine, given twic
Experimental Drug,Placebo Comparator Drug
Low dose pilocarpine ,Placebo tablet
Sponsors
Department of Otolaryngology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Head and neck cancer patients 1.1 Nasopharyngeal cancer 1.2 Oropharyngeal cancer 1.3 Hypopharyngeal cancer 2. Age 18-70 year 3.Adjuvant RT 4.ECOG equal or less than 2
Exclusion criteria
Exclusion criteria: 1. Patients with a history of previous malignancy 2. Patients who have previously received radiation therapy 3. Patients diagnosed with any type of salivary gland carcinoma major and minor salivary glands 4. Patients with underlying conditions causing xerostomia such as Sjogren's syndrome 5. Patients with severe comorbidities such as uncontrolled asthma or cardiovascular diseases 6. Patients with a known allergy to the pilocarpine drug class 7. Patients who have received radiation therapy to only one side of the head and neck region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary flow measurement 6 months Data record,Patient-reported outcome questionnaire for dry mouth (PROM) 6 months Data record | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI 6 months Data record | — |
Countries
Thailand
Contacts
Public ContactPitinuch Bunyapas
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed