NCT04608773 · REGISTRY CONDITION SEARCH

Blinded Dry Mouth Spray Crossover Study

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2024-02-01

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Oral Dryness

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outcome · POSTED

Sleeping Difficulty Due to Oral Dryness

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outcome · POSTED

Speaking Difficulty Due to Oral Dryness

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outcome · POSTED

Taste Alteration/Impairment Due to Oral Dryness

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outcome · POSTED

Swallowing and Chewing Difficulty Due to Oral Dryness

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outcome · POSTED

Saliva PH

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outcome · POSTED

Difficulty Wearing Dental Prostheses (if Applicable)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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)
intervention Names
Other: Remineralizing Extreme Dry Mouth Spray with Xylitol
Device: Alcohol-Free Moisturizing Dry Mouth Spray
label
Biotene Spray, followed by Refresh Spray
type
OTHER
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)
intervention Names
Other: Remineralizing Extreme Dry Mouth Spray with Xylitol
Device: Alcohol-Free Moisturizing Dry Mouth Spray
label
Refresh Spray, followed by Biotene Spray
type
OTHER

interventions

arm Group Labels
Biotene Spray, followed by Refresh Spray
Refresh Spray, followed by Biotene Spray
description
oral hydrating spray
name
Remineralizing Extreme Dry Mouth Spray with Xylitol
other Names
Refresh Oral Hydrating Spray
type
OTHER
arm Group Labels
Biotene Spray, followed by Refresh Spray
Refresh Spray, followed by Biotene Spray
description
oral hydrating spray
name
Alcohol-Free Moisturizing Dry Mouth Spray
other Names
Biotene
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

CROSSOVER

masking Info

masking: QUADRUPLE
masking Description: Both subjects and clinicians will be blinded to Mouth Spray A and Mouth Spray B.
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

OTHER

Enrollment

count: 129
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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"
measure
Oral Dryness
time Frame
2 week trial period

secondary Outcomes

description
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)
measure
Sleeping Difficulty Due to Oral Dryness
time Frame
2 week trial
description
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"
measure
Speaking Difficulty Due to Oral Dryness
time Frame
2 week trial
description
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"
measure
Taste Alteration/Impairment Due to Oral Dryness
time Frame
2 week trial
description
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"
measure
Swallowing and Chewing Difficulty Due to Oral Dryness
time Frame
2 week trial
description
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.
measure
Saliva PH
time Frame
2 week trial
description
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
measure
Difficulty Wearing Dental Prostheses (if Applicable)
time Frame
6 weeks

Full study description

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. 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.

Source references

references

citation
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.
pmid
10435146
type
BACKGROUND
citation
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.
pmid
10789961
type
BACKGROUND
citation
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.
pmid
12903012
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice