Back to resultsArtificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
Primary Purpose
Xerostomia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Artificial saliva containing cumin and ginger extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Artificial saliva containing cumin and ginger extract
Placebo
Arm Description
Artificial saliva containing cumin and ginger extract in spray bottle
Placebo containing composition close to the test group without cumin and ginger extract in spray bottle
Outcomes
Primary Outcome Measures
Amount of saliva
Spit saliva to the bottle for 5 min
Secondary Outcome Measures
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.
Xerostomia questionnaires
Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).
Oral Mucositis Grading Scale
Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).
Adverse reaction: Skin reaction
Found or not found
Adverse reaction: Respiratory reaction
Found or not found
Adverse reaction: Gastrointestinal trat reaction
Found or not found
Quality of life of the patient
Assessment quality of life by patient (scoring 1 to 120 point (high to low quality of life)).
Satisfaction of the patient
Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05872464
Brief Title
Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
Official Title
Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 26, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Artificial saliva containing cumin and ginger extract
Arm Type
Experimental
Arm Description
Artificial saliva containing cumin and ginger extract in spray bottle
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo containing composition close to the test group without cumin and ginger extract in spray bottle
Intervention Type
Other
Intervention Name(s)
Artificial saliva containing cumin and ginger extract
Intervention Description
Artificial saliva containing cumin and ginger extract in spray bottle
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo containing composition close to the test group without cumin and ginger extract in spray bottle
Primary Outcome Measure Information:
Title
Amount of saliva
Description
Spit saliva to the bottle for 5 min
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Acid and base characteristic of saliva
Description
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.
Time Frame
14 days
Title
Xerostomia questionnaires
Description
Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).
Time Frame
14 days
Title
Oral Mucositis Grading Scale
Description
Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).
Time Frame
14 days
Title
Adverse reaction: Skin reaction
Description
Found or not found
Time Frame
14 days
Title
Adverse reaction: Respiratory reaction
Description
Found or not found
Time Frame
14 days
Title
Adverse reaction: Gastrointestinal trat reaction
Description
Found or not found
Time Frame
14 days
Title
Quality of life of the patient
Description
Assessment quality of life by patient (scoring 1 to 120 point (high to low quality of life)).
Time Frame
14 days
Title
Satisfaction of the patient
Description
Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)).
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pornanong Aramwit, Professor
Phone
+66899217255
Email
aramwit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Professor
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
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