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

NCT ID: NCT01885065

Last Updated: 2013-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Cancer of Head and Neck Cancer Radiation-induced Xerostomia Dry Mouth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Gel-based artificial saliva

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

Group Type EXPERIMENTAL

Gel-based artificial saliva

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Oral moisturizing jelly

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role collaborator

Srinakharinwirot University

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role collaborator

Dental Innovation Foundation Under Royal Patronage

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aroonwan Lam-ubol, DDS, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Srinakharinwirot University

Locations

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Mahavachiralongkorn cancer hospital

Pathum Thani, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

Related Links

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http://www.dent-in-found.org/

Dental Innovation Foundation under Royal Patronage, His Majesty the King's Dental Service Unit

Other Identifiers

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DIF-02

Identifier Type: -

Identifier Source: org_study_id

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