This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
73
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth
A non-edible oral lubricating gel for dry mouth patients
Chonburi Cancer Hospital
Chon Buri, Changwat Chon Buri, Thailand
Changes in subjective dry mouth score compared to baseline
Evaluation of subjective dry mouth score by questionaire
Time frame: Baseline, 1 and 2 months after intervention
Changes in objective dry mouth score compared to baseline
Evaluation of objective dry mouth score by oral examination
Time frame: Baseline, 1 and 2 months after intervention
Changes in salivary pH compared to baseline
Evaluation of salivary pH using pH indicator paper
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 1 and 2 months after intervention
Changes in subjective swallow ability compared to baseline
Evaluation of subjective swallow ability using EAT-10 questionaire
Time frame: Baseline, 1 and 2 months after intervention
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Changes in appetite compared to baseline
Evaluation of appetite using questionnaire
Time frame: Baseline, 1 and 2 months after intervention
Changes in tolerance to spicy food
Evaluation of tolerance to spicy food using questionnaire
Time frame: 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
Time frame: Baseline, 1 and 2 months after intervention