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

February 7, 2019 updated by: Dental Innovation Foundation Under Royal Patronage

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Chonburi, Thailand, 20000
        • Chonburi 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in subjective dry mouth score compared to baseline
Time Frame: Baseline, 1 and 2 months after intervention
Evaluation of subjective dry mouth score by questionaire
Baseline, 1 and 2 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in objective dry mouth score compared to baseline
Time Frame: Baseline, 1 and 2 months after intervention
Evaluation of objective dry mouth score by oral examination
Baseline, 1 and 2 months after intervention
Changes in salivary pH compared to baseline
Time Frame: Baseline, 1 and 2 months after intervention
Evaluation of salivary pH using pH indicator paper
Baseline, 1 and 2 months after intervention
Changes in salivary buffering capacity compared to baseline
Time Frame: Baseline, 1 and 2 months after intervention
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
Time Frame: Baseline, 1 and 2 months after intervention
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
Time Frame: Baseline, 1 and 2 months after intervention
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
Time Frame: Baseline, 1 and 2 months after intervention
Evaluation of subjective swallow ability using EAT-10 questionaire
Baseline, 1 and 2 months after intervention
Changes in appetite compared to baseline
Time Frame: Baseline, 1 and 2 months after intervention
Evaluation of appetite using questionnaire
Baseline, 1 and 2 months after intervention
Changes in tolerance to spicy food
Time Frame: Baseline, 1 and 2 months after intervention
Evaluation of tolerance to spicy food using questionnaire
Baseline, 1 and 2 months after intervention
Changes in umami taste recognition threshold compared to baseline
Time Frame: Baseline, 1 and 2 months after intervention
Evaluation of umami taste recognition threshold using filter paper disc method
Baseline, 1 and 2 months after intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dental Innovation Foundation Under Royal Patronage

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mahidol University
Ministry of Health, Thailand
Srinakharinwirot University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aroonwan Lam-ubol, DDS, PhD, Srinakarinwirot 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.

General Publications

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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