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

Not Applicable

Completed

• Conditions: Dry Mouth; Cancer of Head Neck; Radiation-Induced Xerostomia
• Interventions: Dietary Supplement: Oral moisturizing jelly; Other: Artificial saliva

• Registration Number: NCT03035825
• Lead Sponsor: Dental Innovation Foundation Under Royal Patronage

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.

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Study Start: 2017-03-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Moisturizing Jelly	Oral moisturizing jelly	Daily intake of oral moisturizing jelly 5 times/day for two months
Artificial saliva	Artificial saliva	Daily use of non-edible oral lubricating gel 5 times/day for two months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 salivary pH compared to baseline	Baseline, 1 and 2 months after intervention	Evaluation of salivary pH using pH indicator paper
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 subjective swallow ability compared to baseline	Baseline, 1 and 2 months after intervention	Evaluation of subjective swallow ability using EAT-10 questionaire
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

Trial Locations

Locations (1)

Chonburi Cancer Hospital; 🇹🇭 Chonburi, Thailand