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

N/ANot Yet RecruitingNCT05872464

Chulalongkorn University52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Xerostomia

Interventions

Artificial saliva containing cumin and ginger extractOTHER

Artificial saliva containing cumin and ginger extract in spray bottle

PlaceboOTHER

Placebo containing composition close to the test group without cumin and ginger extract in spray bottle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Amount of saliva

Spit saliva to the bottle for 5 min

Time frame: 14 days

Secondary Outcomes

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.

Time frame: 14 days

Xerostomia questionnaires

Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).

Time frame: 14 days

Oral Mucositis Grading Scale

Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).

Time frame: 14 days

Adverse reaction: Skin reaction

Found or not found

Time frame: 14 days

Adverse reaction: Respiratory reaction

Found or not found

Time frame: 14 days

Adverse reaction: Gastrointestinal trat reaction

Found or not found

Time frame: 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)).

Time frame: 14 days

Central Contacts

Pornanong Aramwit, Professor

CONTACT

+66899217255 aramwit@gmail.com

Data from ClinicalTrials.gov

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