NCT01885065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

2 months

First QC Date

June 16, 2013

Last Update Submit

June 19, 2013

Conditions

Cancer of Head and NeckCancerRadiation-induced XerostomiaDry Mouth

Outcome Measures

Primary Outcomes (1)

  • Changes in subjective dry mouth score

    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 Outcomes (3)

  • Changes in objective dry mouth score

    Baseline, 2 week and 4 weeks after the start date

  • Changes in salivary pH

    Baseline, 2 weeks and 4 weeks after the start date

  • Changes in salivary buffering capacity

    Baseline, 2 weeks and 4 weeks after the start date

Study Arms (1)

Gel-based artificial saliva

EXPERIMENTAL

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

Other: Gel-based artificial saliva

Interventions

Gel-based artificial salivaOTHER

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.

Also known as: Oral moisturizing jelly
Gel-based artificial saliva

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahavachiralongkorn cancer hospital

Pathum Thani, Changwat Pathum Thani, 12110, Thailand

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasmsXerostomia

Condition Hierarchy (Ancestors)

Neoplasms by SiteSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Aroonwan Lam-ubol, DDS, PhD

    Faculty of Dentistry, Srinakharinwirot University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2013

First Posted

June 24, 2013

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

TH(1)