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NCT01885065 Clinical Trial

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

Cancer Clinical Trial

Official title:
Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01885065
Other study ID # DIF-02
Secondary ID
Status Completed
Phase N/A
First received June 16, 2013
Last updated June 19, 2013
Start date July 2012
Est. completion date December 2012

Study information
Verified date June 2013
Source Dental Innovation Foundation Under Royal Patronage
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
Thailand Mahavachiralongkorn cancer hospital Pathumthani

Sponsors (5)
Lead Sponsor Collaborator
Dental Innovation Foundation Under Royal Patronage Mahidol University, Ministry of Health, Thailand, Srinakharinwirot University, Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome
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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