Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| TJA Health, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remineralizing Extreme Dry Mouth Spray with Xylitol | Other | oral hydrating spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 2 week trial period |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonas T Johnson, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States | ||
| University of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10435146 | Background | 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. | |
| 10789961 | Background | Warde 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
468 patients were found eligible, 339 declined to participate and 129 were enrolled.
1824 patients were screened for eligibility at UPMC's Head and Neck Cancer Survivorship Clinic between January 2021 and September 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Biotene Spray, Followed by Refresh Spray | 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) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray |
| FG001 | Refresh Spray, Followed by Biotene Spray | 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) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wash Out (1 Week) |
|
| ||||||||||||||||||
| First Intervention (2 Weeks) |
| |||||||||||||||||||
| Second Wash Out (1 Week) |
| |||||||||||||||||||
| Second Intervention (2 Week) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Biotene Spray, Followed by Refresh Spray | 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) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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" | Posted | Mean | Standard Deviation | units on a scale | 2 week trial period |
|
6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biotene Spray | Participants who received biotene spray in either the 1st or 2nd two week trial period |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| oral burning and swelling sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
There may be a degree of attrition bias, our modified intention-to-treat design, in which 13 patients had to be reassigned to group 1 from group 2, may have also added bias; we found no evidence of a sequence effect. The treatment effect of each spray was calculated in reference to use of water, which is known to improve oral dryness so the magnitude of the treatment effect may be underestimated, however, we would expect both products to be affected equally.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Fisher | University of Pittsburgh | 4126479665 | amf91@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2023 | Nov 6, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2022 | Nov 3, 2023 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D014993 | Xylitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Both subjects and clinicians will be blinded to Mouth Spray A and Mouth Spray B.
|
| Alcohol-Free Moisturizing Dry Mouth Spray | Device | oral hydrating spray |
|
|
| 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" | 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" | 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" | 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. | 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 | 6 weeks |
| Pittsburgh |
| Pennsylvania |
| 15219 |
| United States |
| 12903012 | Background | Eisbruch 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. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Refresh Spray, Followed by Biotene Spray | 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) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only participants who completed the protocol were included in the analysis. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Drymouth baseline | Patients responded to electronic survey; the questionnaire included continuous variables derived from the 100mm visual analog scale (VAS). "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" | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | 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) | Number of participants in analysis is less than overall number of participants due to missing responses. | Posted | Mean | Standard Deviation | units on a scale | 2 week trial |
|
|
|
|
| Secondary | 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" | The number of participants in analysis are lower in this specific analysis due to missing data | Posted | Mean | Standard Deviation | units on a scale | 2 week trial |
|
|
|
|
| Secondary | 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" | The number of participants in this analysis are lower than the overall population due to missing data. | Posted | Mean | Standard Deviation | units on a scale | 2 week trial |
|
|
|
|
| Secondary | 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" | Posted | Mean | Standard Deviation | units on a scale | 2 week trial |
|
|
|
|
| Secondary | 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. | The number of participants in this analysis are lower than the overall population due to missing data. | Posted | Mean | Standard Deviation | units on a scale | 2 week trial |
|
|
|
|
| Secondary | 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 | No participants in study with dental prosthesis, therefore data was not collected. | Posted | 6 weeks |
|
|
| 0 |
| 129 |
| 0 |
| 129 |
| 0 |
| 129 |
| EG001 | Refresh Spray | Participants who received Refresh spray in either the 1st or 2nd two week trial period | 0 | 129 | 0 | 129 | 5 | 129 |
Not provided
Not provided
| D009369 |
| Neoplasms |
| Sleep 2 weeks |
|
|
| speaking 2 weeks |
|
|
| Taste 2 weeks |
|
|
| PH 2 weeks |
|
|