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

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05872464
• Other study ID #: Med CU IRB 0489/65
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 26, 2023

Study information

• Verified date: May 2023
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Professor
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: September 26, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Xerostomia

Intervention

Other:
• Artificial saliva containing cumin and ginger extract
Artificial saliva containing cumin and ginger extract in spray bottle
• Placebo
Placebo containing composition close to the test group without cumin and ginger extract in spray bottle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of saliva	Spit saliva to the bottle for 5 min	14 days
Secondary	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
Secondary	Xerostomia questionnaires	Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).	14 days
Secondary	Oral Mucositis Grading Scale	Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).	14 days
Secondary	Adverse reaction: Skin reaction	Found or not found	14 days
Secondary	Adverse reaction: Respiratory reaction	Found or not found	14 days
Secondary	Adverse reaction: Gastrointestinal trat reaction	Found or not found	14 days
Secondary	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
Secondary	Satisfaction of the patient	Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)).	14 days