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

Not Applicable

Not yet recruiting

• Conditions: Xerostomia
• Interventions: Other: Placebo; Other: Artificial saliva containing cumin and ginger extract

• Registration Number: NCT05872464
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Study Start: 2024-07-01
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo containing composition close to the test group without cumin and ginger extract in spray bottle
Artificial saliva containing cumin and ginger extract	Artificial saliva containing cumin and ginger extract	Artificial saliva containing cumin and ginger extract in spray bottle

Primary Outcome Measures

Name	Time	Method
Amount of saliva	14 days	Spit saliva to the bottle for 5 min

Secondary Outcome Measures

Name	Time	Method
Adverse reaction: Respiratory reaction	14 days	Found or not found
Adverse reaction: Skin reaction	14 days	Found or not found
Xerostomia questionnaires	14 days	Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).
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)).
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.
Oral Mucositis Grading Scale	14 days	Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).