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NCT Number: NCT03035825

Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients

This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonburi Cancer Hospital

Chon Buri, Changwat Chon Buri, 20000, Thailand

About this study

Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month.
  • If undergoing chemotherapy, have to finish for at least 2 weeks.
  • Have subjective dry mouth scores at least 3
  • Can perform oral intake without aspiration
  • Can communicate well

Exclusion criteria

  • Has recurrence of cancer
  • Has mucositis more than grade 1
  • Has oral infection such as candidiasis

Treatment and study plan

Oral moisturizing jelly

Dietary Supplement

Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth

Artificial saliva

Other

A non-edible oral lubricating gel for dry mouth patients

Other names: Dry mouth gel

Primary outcomes

  1. Changes in subjective dry mouth score compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of subjective dry mouth score by questionaire

Secondary outcomes

  1. Changes in objective dry mouth score compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of objective dry mouth score by oral examination

  2. Changes in salivary pH compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of salivary pH using pH indicator paper

  3. Changes in salivary buffering capacity compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of salivary buffering capacity using a commercial saliva check buffer kit

  4. Changes in Candidal counts of saliva compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of number of fungal colonies of Candida spp. in saliva by culture

  5. Changes in energy intake compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of energy intake per day using dietary record and analysis

  6. Changes in subjective swallow ability compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of subjective swallow ability using EAT-10 questionaire

  7. Changes in appetite compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of appetite using questionnaire

  8. Changes in tolerance to spicy food

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of tolerance to spicy food using questionnaire

  9. Changes in umami taste recognition threshold compared to baseline

    Time frame: Baseline, 1 and 2 months after intervention

    Evaluation of umami taste recognition threshold using filter paper disc method

Sponsors and collaborators

Lead sponsor

Dental Innovation Foundation Under Royal Patronage

Other

Collaborators

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

Registry information

Official study title

A Randomized Controlled Trial for Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients With Xerostomia

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
Feb 8, 2019

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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