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

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ClinicalTrials.gov Identifier: NCT01885065
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : June 24, 2013
Sponsor:
Collaborators:
Thammasat University
Srinakharinwirot University
Mahidol University
Ministry of Health, Thailand
Information provided by (Responsible Party):
Dental Innovation Foundation Under Royal Patronage

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
Cancer of Head and Neck Cancer Radiation-induced Xerostomia Dry Mouth Other: Gel-based artificial saliva Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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 : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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 Name: Oral moisturizing jelly




Primary Outcome Measures :
  1. Changes in subjective dry mouth score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885065


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

Additional Information:
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Responsible Party: Dental Innovation Foundation Under Royal Patronage
ClinicalTrials.gov Identifier: NCT01885065     History of Changes
Other Study ID Numbers: DIF-02
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
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Xerostomia
Head and Neck Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Neoplasms by Site
Neoplasms