Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients

Study Overview
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Brief Summary
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This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.

Detailed Description
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Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.

Official Title
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A Randomized Controlled Trial for Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients With Xerostomia

Conditions
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Dry Mouth, Cancer of Head Neck, Radiation-Induced Xerostomia

Intervention / Treatment
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* Dietary Supplement: Oral moisturizing jelly
* Other: Artificial saliva


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month. If undergoing chemotherapy, have to finish for at least 2 weeks. Have subjective dry mouth scores at least 3 Can perform oral intake without aspiration Can communicate well Exclusion Criteria: Has recurrence of cancer Has mucositis more than grade 1 Has oral infection such as candidiasis

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Moisturizing Jelly<br>Daily intake of oral moisturizing jelly 5 times/day for two months | Dietary Supplement: Oral moisturizing jelly<br>* Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth<br>|
| Active Comparator: Artificial saliva<br>Daily use of non-edible oral lubricating gel 5 times/day for two months | Other: Artificial saliva<br>* A non-edible oral lubricating gel for dry mouth patients<br>* Other names: Dry mouth gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in subjective dry mouth score compared to baseline | Evaluation of subjective dry mouth score by questionaire | Baseline, 1 and 2 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in objective dry mouth score compared to baseline | Evaluation of objective dry mouth score by oral examination | Baseline, 1 and 2 months after intervention | 
| Changes in salivary pH compared to baseline | Evaluation of salivary pH using pH indicator paper | Baseline, 1 and 2 months after intervention | 
| Changes in salivary buffering capacity compared to baseline | Evaluation of salivary buffering capacity using a commercial saliva check buffer kit | Baseline, 1 and 2 months after intervention | 
| Changes in Candidal counts of saliva compared to baseline | Evaluation of number of fungal colonies of Candida spp. in saliva by culture | Baseline, 1 and 2 months after intervention | 
| Changes in energy intake compared to baseline | Evaluation of energy intake per day using dietary record and analysis | Baseline, 1 and 2 months after intervention | 
| Changes in subjective swallow ability compared to baseline | Evaluation of subjective swallow ability using EAT-10 questionaire | Baseline, 1 and 2 months after intervention | 
| Changes in appetite compared to baseline | Evaluation of appetite using questionnaire | Baseline, 1 and 2 months after intervention | 
| Changes in tolerance to spicy food | Evaluation of tolerance to spicy food using questionnaire | Baseline, 1 and 2 months after intervention | 
| Changes in umami taste recognition threshold compared to baseline | Evaluation of umami taste recognition threshold using filter paper disc method | Baseline, 1 and 2 months after intervention |