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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Xerostomia
• Intervention / Treatment: Other: Artificial saliva containing cumin and ginger extract; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pornanong Aramwit, Professor; Phone Number: +66899217255; Email: aramwit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Pornanong Aramwit, Professor, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Head and Neck Neoplasms; Xerostomia
• Other Study ID Numbers: R177h/66

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No