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

June 19, 2013 updated by: Dental Innovation Foundation Under Royal Patronage

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Pathumthani, Thailand, 12110
        • Mahavachiralongkorn cancer hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gel-based artificial saliva
Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks
Other: Gel-based artificial saliva

Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth.

Taking orally 1-2 teaspoon each time, 5 times / day (30-50 ml/ day) for four weeks.

Other Names:
  • Oral moisturizing jelly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in subjective dry mouth score
Time Frame: 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)
baseline, 2 weeks and 4 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in objective dry mouth score
Time Frame: 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)
Baseline, 2 week and 4 weeks after the start date
Changes in salivary pH
Time Frame: 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)
Baseline, 2 weeks and 4 weeks after the start date
Changes in salivary buffering capacity
Time Frame: 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)
Baseline, 2 weeks and 4 weeks after the start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dental Innovation Foundation Under Royal Patronage

Collaborators

Mahidol University
Ministry of Health, Thailand
Thammasat University
Srinakharinwirot University

Investigators

  • Study Chair: Aroonwan Lam-ubol, DDS, PhD, Faculty of Dentistry, Srinakharinwirot University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 16, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (ESTIMATE)

June 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIF-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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