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Completed

NCT Number: NCT04608773

Blinded Dry Mouth Spray Crossover Study

To identify the effectiveness of two mouth sprays at relieving symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.

To assess patient quality of life and mouth acidity following use of two mouth sprays meant to relieve symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.

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Key information

Conditions

Xerostomia Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Stomatognathic Diseases Xerostomia Following Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC, Pittsburgh, Pennsylvania, United States

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About this study

Investigators have observed that patients at the University of Pittsburgh Medical Center Head and Neck Survivorship clinic with symptoms of radiation-induced xerostomia expressed verbal preference for Biotene and Refresh mouth sprays (spray form of mouthwash) compared to other oral products such as gel, toothpaste, and chewing gum. Investigators have designed this study to specifically assess the effectiveness of mouth sprays on xerostomia in patients who have completed radiation for head and neck carcinoma. While there have been clinical trials to evaluate the effectiveness of Biotene oral products for xerostomia, Refresh mouthwash/mouth spray is a newer oral rinse formula that has not undergone any randomized controlled trials to evaluate its efficacy compared to other agents of its kind. The investigators have put forward this randomized controlled trial to compare the efficacy of both sprays to each other and to water. Biotene spray is cleared by the FDA as a medical device product. Currently, Refresh mouth spray falls under the FD&C Act.

There is preliminary data on the effectiveness of Biotene mouthwash for xerostomia in patients who have had radiation of the head and neck. A phase II study of Biotene products (mouthwash, chewing gum, and toothpaste) were effective at improving many symptoms of post-irradiation xerostomia. Numerous other studies have shown that mouthwash and topical dry mouth products improve xerostomia symptoms.

Xerostomia, or mouth dryness, is a frequent side effect of head and neck cancer radiation therapy, as the salivary glands are often damaged during therapy. Radiation therapy can be successful in treating cancer, but post-irradiation xerostomia can cause oral discomfort as well as issues with eating, speech, and oral hygiene, leading to significantly decreased quality of life. While treatment of xerostomia has limited benefit, various mouthwashes have led to major symptomatic improvement in some patients. This study will add to existing literature by commenting on efficacy of a popular and established mouth spray used for xerostomia as well as a new mouth spray that has not been compared to existing formulas. A double-blinded randomized controlled trial evaluating these mouth sprays will add information about value of both formulas for head and neck carcinoma survivors with radiation-induced xerostomia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • biopsy-proven oral cavity, oropharynx, larynx, and hypopharynx carcinoma
  • who received primary radiation with curative intent (>50 Gray in 20 fractions)
  • radiation treatment completed greater than 6 months ago
  • who endorse xerostomia

Exclusion criteria

  • evidence of metastasis or recurrent disease
  • Current use of pilocarpine, antidepressants, anticholinergic drugs, or any other medication that has an effect on salivation
  • those who have documented medical conditions associated with xerostomia such as Sjogren's Syndrome
  • those who use oral inhalants for the treatment of respiratory disease

Treatment and study plan

Remineralizing Extreme Dry Mouth Spray with Xylitol

Other

oral hydrating spray

Other names: Refresh Oral Hydrating Spray

Alcohol-Free Moisturizing Dry Mouth Spray

Device

oral hydrating spray

Other names: Biotene

Primary outcomes

  1. Oral Dryness

    Time frame: 2 week trial period

    at the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics.

    Dryness was measured on a 0-100 point scale "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"

Secondary outcomes

  1. Sleeping Difficulty Due to Oral Dryness

    Time frame: 2 week trial

    sleeping difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Sleeping difficulty will be measured on a 0-100 point scale

    "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to sleep? Consider such factors as how difficult it was for you to go to sleep, the duration and quality of your sleep, and how often you woke up to drink or urinate. Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy" (Higher score means better outcome)

  2. Speaking Difficulty Due to Oral Dryness

    Time frame: 2 week trial

    Speaking difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Speaking difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to speak without drinking liquids? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"

  3. Taste Alteration/Impairment Due to Oral Dryness

    Time frame: 2 week trial

    Alteration/impairment in sense of taste will be documented via questionnaire completion by participants administered via Qualtrics. Taste alteration/impairment will be measured on a 0-100 point scale "During the last three days, has your sense of taste been impaired or affected? Greatly Impaired/Affected 0 10 20 30 40 50 60 70 80 90 100 Not Impaired/Affected"

  4. Swallowing and Chewing Difficulty Due to Oral Dryness

    Time frame: 2 week trial

    Swallowing and chewing difficulty due to oral dryness will be documented via questionnaire completion by participants administered via Qualtrics. Swallowing and chewing difficulty will be measured on a 0-100 point scale "During the last three days, overall, due to the dryness of your mouth and tongue, how difficult was it to chew and swallow food? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"

  5. Saliva PH

    Time frame: 2 week trial

    PH Is a measure of acidity on a logarithmic scale range 0 (most acidic) to 14 (most basic) with a neutral PH of 7 as the desired outcome.

  6. Difficulty Wearing Dental Prostheses (if Applicable)

    Time frame: 6 weeks

    Difficulty wearing dental prostheses (if applicable) will be documented via questionnaire completion by participants administered via Qualtrics. Dental prostheses wearing difficulty will be measured on a 0-100 point scale "If you normally wear dentures, due to the dryness of your mouth and tongue, how difficult was it to wear dentures during the last three days? (If you do not normally wear dentures or could not wear dentures for other reasons not associated with dry mouth, please check the box marked "Not applicable") Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy Not Applicable

Sponsors and collaborators

Lead sponsor

Jonas Johnson

Other

Collaborators

  • TJA Health, LLC

Registry information

Official study title

Evaluation of Two Mouth Sprays for Post-irradiation Xerostomia in Head and Neck Cancer Survivors: a Randomized, Double-blind Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 29, 2020
Registry last updated
Feb 1, 2024

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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