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

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

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

Study Overview

• Status: Completed
• Conditions: Dry Mouth; Radiation-Induced Xerostomia; Cancer of Head Neck
• Intervention / Treatment: Dietary supplement: Oral moisturizing jelly; Other: Artificial saliva

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chonburi, Thailand, 20000
    • Chonburi Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dental Innovation Foundation Under Royal Patronage
• Collaborators: Mahidol University; Ministry of Health, Thailand; Srinakharinwirot University
• Investigators: Principal Investigator: Aroonwan Lam-ubol, DDS, PhD, Srinakarinwirot University

Publications and helpful links

General Publications

• Lam-Ubol A, Matangkasombut O, Trachootham D, Tarapan S, Sattabanasuk V, Talungchit S, Paemuang W, Phonyiam T, Chokchaitam O, Mungkung OO. Efficacy of gel-based artificial saliva on Candida colonization and saliva properties in xerostomic post-radiotherapy head and neck cancer patients: a randomized controlled trial. Clin Oral Investig. 2021 Apr;25(4):1815-1827. doi: 10.1007/s00784-020-03484-1. Epub 2020 Aug 10.
• Nuchit S, Lam-Ubol A, Paemuang W, Talungchit S, Chokchaitam O, Mungkung OO, Pongcharoen T, Trachootham D. Alleviation of dry mouth by saliva substitutes improved swallowing ability and clinical nutritional status of post-radiotherapy head and neck cancer patients: a randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2817-2828. doi: 10.1007/s00520-019-05132-1. Epub 2019 Nov 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): January 30, 2019
• Study Completion (ACTUAL): January 30, 2019

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (ESTIMATE): January 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Head and Neck Neoplasms; Xerostomia
• Other Study ID Numbers: DIF-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No