Blinded Dry Mouth Spray Crossover Study

Jonas Johnson

Status: Completed

Conditions: Xerostomia; Xerostomia Following Radiotherapy; Head and Neck Cancer

Treatments: Device: Alcohol-Free Moisturizing Dry Mouth Spray; Other: Remineralizing Extreme Dry Mouth Spray with Xylitol

Study type: Interventional

Funder types: Other

Identifiers

NCT04608773

STUDY20090008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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129 participants in 2 patient groups

Biotene Spray, followed by Refresh Spray

Other group

Description:

The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)

Treatment:

Device: Alcohol-Free Moisturizing Dry Mouth Spray

Other: Remineralizing Extreme Dry Mouth Spray with Xylitol

Refresh Spray, followed by Biotene Spray

Other group

Description:

The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)

Treatment:

Device: Alcohol-Free Moisturizing Dry Mouth Spray

Other: Remineralizing Extreme Dry Mouth Spray with Xylitol