Blinded Dry Mouth Spray Crossover Study

Registration Number
NCT04608773
Lead Sponsor
Jonas Johnson
Brief Summary

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.
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Detailed 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 designe...

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
129
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Biotene Spray, followed by Refresh SprayRemineralizing Extreme Dry Mouth Spray with XylitolThe 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)
Refresh Spray, followed by Biotene SprayRemineralizing Extreme Dry Mouth Spray with XylitolThe 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)
Biotene Spray, followed by Refresh SprayAlcohol-Free Moisturizing Dry Mouth SprayThe 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)
Refresh Spray, followed by Biotene SprayAlcohol-Free Moisturizing Dry Mouth SprayThe 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)
Primary Outcome Measures
NameTimeMethod
Oral Dryness2 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.
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Secondary Outcome Measures
NameTimeMethod
Speaking Difficulty Due to Oral Dryness2 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 9...

Sleeping Difficulty Due to Oral Dryness2 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
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Taste Alteration/Impairment Due to Oral Dryness2 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...

Swallowing and Chewing Difficulty Due to Oral Dryness2 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 Diffi...

Saliva PH2 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.

Difficulty Wearing Dental Prostheses (if Applicable)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 d...

Trial Locations

Locations (2)

University of Pittsburgh

🇺🇸

Pittsburgh, Pennsylvania, United States

UPMC

🇺🇸

Pittsburgh, Pennsylvania, United States

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