Cancer Clinical Trial
Official title:
Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 80 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Thailand | Mahavachiralongkorn cancer hospital | Pathumthani |
Lead Sponsor | Collaborator |
---|---|
Dental Innovation Foundation Under Royal Patronage | Mahidol University, Ministry of Health, Thailand, Srinakharinwirot University, Thammasat University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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) | Baseline, 2 week and 4 weeks after the start date | No |
Secondary | 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) | Baseline, 2 weeks and 4 weeks after the start date | No |
Secondary | 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) | Baseline, 2 weeks and 4 weeks after the start date | No |
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