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

Dry Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035825
• Other study ID #: DIF-05
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: February 2019
• Source: Dental Innovation Foundation Under Royal Patronage
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Head Neck
• Dry Mouth
• Head and Neck Neoplasms
• Radiation-Induced Xerostomia
• Xerostomia

Intervention

Dietary Supplement:
• Oral moisturizing jelly
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth

Other:
• Artificial saliva
A non-edible oral lubricating gel for dry mouth patients

Locations

Country	Name	City	State
Thailand	Chonburi Cancer Hospital	Chonburi

Sponsors (4)

Lead Sponsor	Collaborator
Dental Innovation Foundation Under Royal Patronage	Mahidol University, Ministry of Health, Thailand, Srinakharinwirot University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Changes in salivary pH compared to baseline	Evaluation of salivary pH using pH indicator paper	Baseline, 1 and 2 months after intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in subjective swallow ability compared to baseline	Evaluation of subjective swallow ability using EAT-10 questionaire	Baseline, 1 and 2 months after intervention
Secondary	Changes in appetite compared to baseline	Evaluation of appetite using questionnaire	Baseline, 1 and 2 months after intervention
Secondary	Changes in tolerance to spicy food	Evaluation of tolerance to spicy food using questionnaire	Baseline, 1 and 2 months after intervention
Secondary	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