XerostomiaNCT04608773
Blinded Dry Mouth Spray Crossover Study
A study testing Remineralizing Extreme Dry Mouth Spray with Xylitol and Alcohol-Free Moisturizing Dry Mouth Spray in people with Xerostomia and Head and Neck Cancer, run by Jonas Johnson at 2 sites in United States.
Trial 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. 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Head and Neck Cancer, Xerostomia Following Radiotherapy
- What is being tested?
- Remineralizing Extreme Dry Mouth Spray with Xylitol and Alcohol-Free Moisturizing Dry Mouth Spray
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jan 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
UPMC
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Evaluation of Two Mouth Sprays for Post-irradiation Xerostomia in Head and Neck Cancer Survivors: a Randomized, Double-blind Clinical Trial
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.
Read the 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 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.
- Being tested
- Remineralizing Extreme Dry Mouth Spray with Xylitol, Alcohol-Free Moisturizing Dry Mouth Spray
- Keywords
- Mouth Spray
- Medical subject headings
- Xerostomia, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remineralizing Extreme Dry Mouth Spray with XylitolOther
Also called Refresh Oral Hydrating Spray
oral hydrating spray
Alcohol-Free Moisturizing Dry Mouth SprayDevice
Also called Biotene
oral hydrating spray
| Study group | Role | What they receive |
|---|---|---|
| Biotene Spray, followed by Refresh Spray | Other | 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) Receives: Other: Remineralizing Extreme Dry Mouth Spray with Xylitol; Device: Alcohol-Free Moisturizing Dry Mouth Spray |
| Refresh Spray, followed by Biotene Spray | Other | 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) Receives: Other: Remineralizing Extreme Dry Mouth Spray with Xylitol; Device: Alcohol-Free Moisturizing Dry Mouth Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Dryness
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"
Measured: 2 week trial period
Secondary outcomes (6)
Sleeping Difficulty Due to Oral Dryness
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)
Measured: 2 week trial
Speaking Difficulty Due to Oral Dryness
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"
Measured: 2 week trial
Taste Alteration/Impairment Due to Oral Dryness
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"
Measured: 2 week trial
Swallowing and Chewing Difficulty Due to Oral Dryness
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"
Measured: 2 week trial
Saliva PH
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.
Measured: 2 week trial
Difficulty Wearing Dental Prostheses (if Applicable)
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start14 Jan 2021
- Primary completion15 Nov 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonas Johnson
- Sponsor type
- University, hospital or other
- Collaborators
- TJA Health, LLC
- Responsible party
- Sponsor-investigator, Jonas Johnson, University of Pittsburgh
- Investigators
- Jonas T Johnson, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608773
- Sponsor's protocol ID
- STUDY20090008
- Status last verified
- Jan 2024
- First submitted
- 18 Oct 2020
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Epstein JB, Emerton S, Le ND, Stevenson-Moore P. A double-blind crossover trial of Oral Balance gel and Biotene toothpaste versus placebo in patients with xerostomia following radiation therapy. Oral Oncol. 1999 Mar;35(2):132-7. doi: 10.1016/s1368-8375(98)00109-2.
PubMed 10435146Warde P, Kroll B, O'Sullivan B, Aslanidis J, Tew-George E, Waldron J, Maxymiw W, Liu FF, Payne D, Cummings B. A phase II study of Biotene in the treatment of postradiation xerostomia in patients with head and neck cancer. Support Care Cancer. 2000 May;8(3):203-8. doi: 10.1007/s005200050286.
PubMed 10789961Eisbruch A, Rhodus N, Rosenthal D, Murphy B, Rasch C, Sonis S, Scarantino C, Brizel D. How should we measure and report radiotherapy-induced xerostomia? Semin Radiat Oncol. 2003 Jul;13(3):226-34. doi: 10.1016/S1053-4296(03)00033-X.
PubMed 12903012
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Mouth Sprays for Post-irradiation Xerostomia in Head and Neck Cancer Survivors: a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04608773
- Acronym / sponsor ID
- STUDY20090008
- Keywords
- Mouth Spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Jonas JohnsonUniversity, hospital or other
- Collaborators
- TJA Health, LLC
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biotene Spray, followed by Refresh Spray | Other | Other: Remineralizing Extreme Dry Mouth Spray with Xylitol, Device: Alcohol-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 Spray | Other | Other: Remineralizing Extreme Dry Mouth Spray with Xylitol, Device: Alcohol-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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remineralizing Extreme Dry Mouth Spray with XylitolAlso: Refresh Oral Hydrating Sprayoral hydrating spray | Other | Biotene Spray, followed by Refresh Spray, Refresh Spray, followed by Biotene Spray |
| Alcohol-Free Moisturizing Dry Mouth SprayAlso: Bioteneoral hydrating spray | Device | Biotene Spray, followed by Refresh Spray, Refresh Spray, followed by Biotene Spray |
Primary outcome
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"
6 secondary outcomes
Sleeping Difficulty Due to Oral Dryness
Time frame: 2 week trial
Speaking Difficulty Due to Oral Dryness
Time frame: 2 week trial
Taste Alteration/Impairment Due to Oral Dryness
Time frame: 2 week trial
Swallowing and Chewing Difficulty Due to Oral Dryness
Time frame: 2 week trial
Saliva PH
Time frame: 2 week trial
Difficulty Wearing Dental Prostheses (if Applicable)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10435146Epstein JB, Emerton S, Le ND, Stevenson-Moore P. A double-blind crossover trial of Oral Balance gel and Biotene toothpaste versus placebo in patients with xerostomia following radiation therapy. Oral Oncol. 1999 Mar;35(2):132-7. doi: 10.1016/s1368-8375(98)00109-2.
- Background: PubMed 10789961Warde P, Kroll B, O'Sullivan B, Aslanidis J, Tew-George E, Waldron J, Maxymiw W, Liu FF, Payne D, Cummings B. A phase II study of Biotene in the treatment of postradiation xerostomia in patients with head and neck cancer. Support Care Cancer. 2000 May;8(3):203-8. doi: 10.1007/s005200050286.
- Background: PubMed 12903012Eisbruch A, Rhodus N, Rosenthal D, Murphy B, Rasch C, Sonis S, Scarantino C, Brizel D. How should we measure and report radiotherapy-induced xerostomia? Semin Radiat Oncol. 2003 Jul;13(3):226-34. doi: 10.1016/S1053-4296(03)00033-X.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas T Johnson, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remineralizing Extreme Dry Mouth Spray with Xylitol and Alcohol-Free Moisturizing Dry Mouth Spray in people with Xerostomia and Head and Neck Cancer, run by Jonas Johnson at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Dryness (time frame: 2 week trial period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608773, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.