Xerostomia
Conditions
Brief summary
The objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.
Detailed description
There are 52 patients in this study. They are divided into 2 groups which are artificial saliva containing cumin and ginger extract group (test group) 26 patients and placebo group 26 patients. The patients spray the sample into the mouth 3 times/day for 14 day. Amount of saliva, pH of saliva, xerostomia questionnaires, WHO Oral Mucositis Grading Scale, quality of life, adverse events, and satisfaction were assessed.
Interventions
Artificial saliva containing cumin and ginger extract in spray bottle
OTHERPlacebo
Placebo containing composition close to the test group without cumin and ginger extract in spray bottle
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age more than 18 years * Head and neck cancer with xerostomia * 6 months post radiation * Willing to participate in this study
Exclusion criteria
* Sialolith or Sjogren's syndrome * Uncontrolled cancer * Using artificial saliva more than 2 weeks * Taking Pilocarpine or cevimeline more than 2 weeks * Allergic to cumin, ginger, xylitol, and glycerin * History of other oral mucosal diseases * Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of saliva | 14 days | Spit saliva to the bottle for 5 min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Xerostomia questionnaires | 14 days | Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)). |
| Oral Mucositis Grading Scale | 14 days | Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)). |
| Adverse reaction: Skin reaction | 14 days | Found or not found |
| Acid and base characteristic of saliva | 14 days | Spit saliva to the bottle, then take 1 piece of pH strip and dip it into the saliva for 30 seconds. Compare the color of the dipped pH strip to the color chart on pH strip box. The result shows value at pH 1-14. |
| Adverse reaction: Gastrointestinal trat reaction | 14 days | Found or not found |
| Quality of life of the patient | 14 days | Assessment quality of life by patient (scoring 1 to 120 point (high to low quality of life)). |
| Satisfaction of the patient | 14 days | Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)). |
| Adverse reaction: Respiratory reaction | 14 days | Found or not found |
Contacts
Primary ContactPornanong Aramwit, Professor
Outcome results
None listed