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

Sponsor
Dental Innovation Foundation Under Royal Patronage (Other)
Overall Status
Completed
CT.gov ID
NCT01885065
Collaborator
Thammasat University (Other), Srinakharinwirot University (Other), Mahidol University (Other), Ministry of Health, Thailand (Other)
25
Enrollment
1
Location
1
Arm
5
Duration (Months)
5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Gel-based artificial saliva
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gel-based artificial saliva

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

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.
Other Names:
  • Oral moisturizing jelly

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in subjective dry mouth score [baseline, 2 weeks and 4 weeks after intervention]

      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

    1. Changes in objective dry mouth score [Baseline, 2 week and 4 weeks after the start date]

      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)

    2. Changes in salivary pH [Baseline, 2 weeks and 4 weeks after the start date]

      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)

    3. Changes in salivary buffering capacity [Baseline, 2 weeks and 4 weeks after the start date]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mahavachiralongkorn cancer hospital Pathumthani Thailand 12110

    Sponsors and Collaborators

    • Dental Innovation Foundation Under Royal Patronage
    • Thammasat University
    • Srinakharinwirot University
    • Mahidol University
    • Ministry of Health, Thailand

    Investigators

    • Study Chair: Aroonwan Lam-ubol, DDS, PhD, Faculty of Dentistry, Srinakharinwirot University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Dental Innovation Foundation Under Royal Patronage
    ClinicalTrials.gov Identifier:
    NCT01885065
    Other Study ID Numbers:
    • DIF-02
    First Posted:
    Jun 24, 2013
    Last Update Posted:
    Jun 24, 2013
    Last Verified:
    Jun 1, 2013
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Xerostomia

    Study Results

    No Results Posted as of Jun 24, 2013