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

• Sponsor: Dental Innovation Foundation Under Royal Patronage (Other)
• Overall Status: Completed
• CT.gov ID: NCT03035825
• Collaborator: Mahidol University (Other), Srinakharinwirot University (Other), Ministry of Health, Thailand (Other)
• Enrollment: 73
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer of Head Neck; Radiation-Induced Xerostomia; Dry Mouth	Dietary Supplement: Oral moisturizing jelly; Other: Artificial saliva	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Jan 30, 2019
• Actual Study Completion Date: Jan 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Changes in salivary pH compared to baseline [Baseline, 1 and 2 months after intervention]

   Evaluation of salivary pH using pH indicator paper

3. 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

4. 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

5. 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

6. Changes in subjective swallow ability compared to baseline [Baseline, 1 and 2 months after intervention]

   Evaluation of subjective swallow ability using EAT-10 questionaire

7. Changes in appetite compared to baseline [Baseline, 1 and 2 months after intervention]

   Evaluation of appetite using questionnaire

8. Changes in tolerance to spicy food [Baseline, 1 and 2 months after intervention]

   Evaluation of tolerance to spicy food using questionnaire

9. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonburi Cancer Hospital	Chonburi		Thailand	20000

Sponsors and Collaborators

• Dental Innovation Foundation Under Royal Patronage
• Mahidol University
• Srinakharinwirot University
• Ministry of Health, Thailand

Investigators

• Principal Investigator: Aroonwan Lam-ubol, DDS, PhD, Srinakarinwirot University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dental Innovation Foundation Under Royal Patronage
• ClinicalTrials.gov Identifier: NCT03035825
• Other Study ID Numbers: DIF-05
• First Posted: Jan 30, 2017
• Last Update Posted: Feb 8, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Head and Neck Neoplasms; Xerostomia

Study Results

No Results Posted as of Feb 8, 2019