Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
N/A
35 Years
80 Years
35 Years
80 Years
Not Enrolling
Both
Cancer of Head and Neck, Cancer, Radiation-induced Xerostomia, Dry Mouth
Both
Cancer of Head and Neck, Cancer, Radiation-induced Xerostomia, Dry Mouth
Trial Information
Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Changes in subjective dry mouth score
Outcome 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)
Outcome Time Frame:
baseline, 2 weeks and 4 weeks after intervention
Safety Issue:
No
Principal Investigator
Aroonwan Lam-ubol, DDS, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Faculty of Dentistry, Srinakharinwirot University
Authority:
Thailand: Ethical Committee
Study ID:
DIF-02
NCT ID:
NCT01885065
Start Date:
July 2012
Completion Date:
December 2012
Related Keywords:
- Cancer of Head and Neck
- Cancer
- Radiation-Induced Xerostomia
- Dry Mouth
- Head and Neck Neoplasms
- Xerostomia
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