Cancer of Head Neck, Dry Mouth, Radiation-Induced Xerostomia
Conditions
Brief summary
This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOral moisturizing jelly
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth
OTHERArtificial saliva
A non-edible oral lubricating gel for dry mouth patients
Sponsors
Mahidol University
Srinakharinwirot University
Ministry of Health, Thailand
Dental Innovation Foundation Under Royal Patronage
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month. 2. If undergoing chemotherapy, have to finish for at least 2 weeks. 3. Have subjective dry mouth scores at least 3 4. Can perform oral intake without aspiration 5. Can communicate well
Exclusion criteria
1. Has recurrence of cancer 2. Has mucositis more than grade 1 3. Has oral infection such as candidiasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in subjective dry mouth score compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of subjective dry mouth score by questionaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in salivary pH compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of salivary pH using pH indicator paper |
| Changes in salivary buffering capacity compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of salivary buffering capacity using a commercial saliva check buffer kit |
| Changes in Candidal counts of saliva compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of number of fungal colonies of Candida spp. in saliva by culture |
| Changes in energy intake compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of energy intake per day using dietary record and analysis |
| Changes in objective dry mouth score compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of objective dry mouth score by oral examination |
| Changes in appetite compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of appetite using questionnaire |
| Changes in tolerance to spicy food | Baseline, 1 and 2 months after intervention | Evaluation of tolerance to spicy food using questionnaire |
| Changes in umami taste recognition threshold compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of umami taste recognition threshold using filter paper disc method |
| Changes in subjective swallow ability compared to baseline | Baseline, 1 and 2 months after intervention | Evaluation of subjective swallow ability using EAT-10 questionaire |
Countries
Thailand
Outcome results
None listed