Back to resultsEfficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients
Primary Purpose
Cancer of Head and Neck, Cancer, Radiation-induced Xerostomia
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Gel-based artificial saliva
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer of Head and Neck
Eligibility Criteria
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
Sites / Locations
- Mahavachiralongkorn cancer hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gel-based artificial saliva
Arm Description
Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Changes in objective dry mouth score
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
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
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)
Full Information
NCT ID
NCT01885065
First Posted
June 16, 2013
Last Updated
June 19, 2013
Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Thammasat University, Srinakharinwirot University, Mahidol University, Ministry of Health, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT01885065
Brief Title
Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients
Official Title
Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Thammasat University, Srinakharinwirot University, Mahidol University, Ministry of Health, Thailand
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck, Cancer, Radiation-induced Xerostomia, Dry Mouth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gel-based artificial saliva
Arm Type
Experimental
Arm Description
Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks
Intervention Type
Other
Intervention Name(s)
Gel-based artificial saliva
Other Intervention Name(s)
Oral moisturizing jelly
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in subjective dry mouth score
Description
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)
Time Frame
baseline, 2 weeks and 4 weeks after intervention
Secondary Outcome Measure Information:
Title
Changes in objective dry mouth score
Description
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)
Time Frame
Baseline, 2 week and 4 weeks after the start date
Title
Changes in salivary pH
Description
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)
Time Frame
Baseline, 2 weeks and 4 weeks after the start date
Title
Changes in salivary buffering capacity
Description
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)
Time Frame
Baseline, 2 weeks and 4 weeks after the start date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aroonwan Lam-ubol, DDS, PhD
Organizational Affiliation
Faculty of Dentistry, Srinakharinwirot University
Official's Role
Study Chair
Facility Information:
Facility Name
Mahavachiralongkorn cancer hospital
City
Pathumthani
ZIP/Postal Code
12110
Country
Thailand
12. IPD Sharing Statement
Links:
URL
http://www.dent-in-found.org/
Description
Dental Innovation Foundation under Royal Patronage, His Majesty the King's Dental Service Unit
Learn more about this trial
Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients
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