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NCT Number: NCT01885065

Efficacy of Novel Edible Gel-based Artificial Saliva in 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.

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Key information

Conditions

Cancer of Head and Neck Cancer Dry Mouth Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Radiation-Induced Xerostomia Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahavachiralongkorn cancer hospital

Pathum Thani, Changwat Pathum Thani, 12110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gel-based artificial saliva

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Dental Innovation Foundation Under Royal Patronage

Other

Collaborators

  • Mahidol University
  • Ministry of Health, Thailand
  • Srinakharinwirot University
  • Thammasat University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 24, 2013
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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