Cancer, Cancer of Head and Neck, Dry Mouth, Radiation-induced Xerostomia
Conditions
Brief summary
The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.
Interventions
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth. Taking orally 1-2 teaspoon each time, 5 times / day (30-50 ml/ day) for four weeks.
Sponsors
Thammasat University
Srinakharinwirot University
Mahidol University
Ministry of Health, Thailand
Dental Innovation Foundation Under Royal Patronage
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* cancer patients who receive/ had received radiotherapy and/or chemotherapy and have dry mouth problems
Exclusion criteria
* mucositis more than grade 1 * cannot perform oral intake of gel-based artificial saliva eg. aspirate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in subjective dry mouth score | baseline, 2 weeks and 4 weeks after intervention | The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in objective dry mouth score | Baseline, 2 week and 4 weeks after the start date | The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week) |
| Changes in salivary pH | Baseline, 2 weeks and 4 weeks after the start date | The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week) |
| Changes in salivary buffering capacity | Baseline, 2 weeks and 4 weeks after the start date | The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week) |
Countries
Thailand
Outcome results
None listed