Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients

Not Applicable

Completed

• Conditions: Cancer of Head and Neck; Radiation-induced Xerostomia; Cancer; Dry Mouth
• Interventions: Other: Gel-based artificial saliva

• Registration Number: NCT01885065
• Lead Sponsor: Dental Innovation Foundation Under Royal Patronage

Brief Summary

The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-06
• Study First Submitted: 2013-06-16
• Study First Submitted QC: 2013-06-19
• Last Update Submitted: 2013-06-19
• Study First Posted: 2013-06-24
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• cancer patients who receive/ had received radiotherapy and/or chemotherapy and have dry mouth problems

Exclusion Criteria

• mucositis more than grade 1
• cannot perform oral intake of gel-based artificial saliva eg. aspirate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gel-based artificial saliva	Gel-based artificial saliva	Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks

Primary Outcome Measures

Name	Time	Method
Changes in subjective dry mouth score	baseline, 2 weeks and 4 weeks after intervention	The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)

Secondary Outcome Measures

Name	Time	Method
Changes in objective dry mouth score	Baseline, 2 week and 4 weeks after the start date	The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Changes in salivary buffering capacity	Baseline, 2 weeks and 4 weeks after the start date	The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Changes in salivary pH	Baseline, 2 weeks and 4 weeks after the start date	The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)

Trial Locations

Locations (1)

Mahavachiralongkorn cancer hospital; 🇹🇭 Pathumthani, Thailand