Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

Conditions
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Xerostomia

Intervention / Treatment
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* Other: Artificial saliva containing cumin and ginger extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial saliva containing cumin and ginger extract<br>Artificial saliva containing cumin and ginger extract in spray bottle | Other: Artificial saliva containing cumin and ginger extract<br>* Artificial saliva containing cumin and ginger extract in spray bottle<br>|
| Placebo Comparator: Placebo<br>Placebo containing composition close to the test group without cumin and ginger extract in spray bottle | Other: Placebo<br>* Placebo containing composition close to the test group without cumin and ginger extract in spray bottle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of saliva | Spit saliva to the bottle for 5 min | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acid and base characteristic of saliva | 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. | 14 days | 
| Xerostomia questionnaires | Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)). | 14 days | 
| Oral Mucositis Grading Scale | Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)). | 14 days | 
| Adverse reaction: Skin reaction | Found or not found | 14 days | 
| Adverse reaction: Respiratory reaction | Found or not found | 14 days | 
| Adverse reaction: Gastrointestinal trat reaction | Found or not found | 14 days | 
| Quality of life of the patient | Assessment quality of life by patient (scoring 1 to 120 point (high to low quality of life)). | 14 days | 
| Satisfaction of the patient | Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)). | 14 days |