XerostomiaNCT03400969
Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
A study testing Glycerol 17%, Aequasyal (OGT) and Salient (new product) in people with Xerostomia, run by University of Bergen at 1 site in Norway.
Trial summary
This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Xerostomia
- What is being tested?
- Glycerol 17%, Aequasyal (OGT) and Salient (new product)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2018to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients have xerostomia (subjective feeling of dry mouth). 2
- The patients are palliative and in institutionalized care.
- Curative treatment of existing diseases has been completed.
- WHOs functional status 3/Karnofsky functional status 30 - 40 % (only capable of limited self-care, tied to bed or chair more than 50% of wake time).
- Participants are cognitively functioning, capable of and willing to consent, capable of giving responses to a limited questionnaire and are expected to remain at the care centre for a minimum of 3 days.
Who cannot join
- Patients treated with radiotherapy in head and neck region.
- -
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
University of Bergen
Bergen, Hordaland, 5099
Signe Solberg, +47 55 58 66 88, signe.solberg@uib.no
Anne Åstrøm, PhD, +47 55 58 64 83, anne.astrom@uib.no
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient.
Read the detailed description
Background:
A majority of patients in palliative care have problems with dry mouth caused by medication or as a direct result of the mortal condition. Dry mouth will cause a variety of problems that commonly affect the disease negatively and contribute to reduced quality of life in the patient's last stage of life. A Cochrane review from 2011 concludes that "there are several moisturising agents available, but no strong evidence that any topical therapy is effective for relieving the symptom of dry mouth." It also concludes that "Oxygenated glycerol triester (OGT) oral spray is more effective than an aqueous electrolyte spray."1
Objectives:
To compare the effectiveness of 3 different oral moisturisers, ; 17 % watery solution of glycerol, OGT oral spray, Aequasyal® and a newly developed product, Salient®.
Methods/design:
30 patients will be recruited from a Norwegian palliative care unit. Eligibility criteria for participants are:
- The patients have xerostomia (subjective feeling of dry mouth). 2
- The patients are palliative and in institutionalized care.
- Curative treatment of existing diseases has been completed.
- WHOs functional status 3/Karnofsky functional status 30 - 40 % (only capable of limited self-care, tied to bed or chair more than 50% of wake time).3, 4
- Participants are cognitively functioning, capable of and willing to consent, capable of giving responses to a limited questionnaire and are expected to remain at the care centre for a minimum of 3 days.
Patients treated with radiotherapy in head and neck region, are excluded from this trial.
The different moisturizers will be compared in a double blind, cross-over design. All patients will be randomized to all three treatments in the cross-over trial, with a minimum of 24 hours wash-out period between the treatments. Patient responses will be collected at baseline, immediately after exposure and after 2 hours. Medical history and medication will be recorded. Primary outcome variables are the subjective feeling of xerostomia, pain/discomfort and speech disturbance.
Ethical considerations:
An application for approval of this study will be sent to the Regional Ethical Committee (REC). There are no known side effects of the agents or methods that will be applied.
Discussion:
To the investigators knowledge, the proposed randomized controlled trial of the effect of three different oral moisturizers will be the first study of this kind to be performed in patients in palliative institutionalized ward. There are no known adverse effects of the products used in this study.
- Conditions
- Xerostomia
- Being tested
- Glycerol 17%, Aequasyal (OGT), Salient (new product)
- Keywords
- Palliative, Moisturisers, Dry mouth, Xerostomia
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerol 17%Device
Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist.
Aequasyal (OGT)Device
Aequasyl (OGT) will be sprayed on the mucosa, at the end of the oral care procedure, preformed by a dentist.
Salient (new product)Device
Salient (new Product) will be applied/given on a spoon, at the end of the oral care procedure, preformed by a dentist.
| Study group | Role | What they receive |
|---|---|---|
| Glycerol 17 % | Active comparator | Oral moisturizer Receives: Device: Glycerol 17% |
| Aequasyal (OGT) | Active comparator | Oral moisturizer Receives: Device: Aequasyal (OGT) |
| Salient (new product) | Active comparator | Oral moisturizer Receives: Device: Salient (new product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective xerostomia
Measured on a 5-point Likert-scale:
Subjective feeling of dry mouth:
- Not dry
- Insignificantly dry
- Fairly dry
- Almost completely dry
- Completely dry
Measured: 3 days
Secondary outcomes (4)
Pain/discomfort
Measured on a 5-point Likert-scale:
Subjective feeling pain/discomfort:
- No pain
- Insignificant pain/discomfort
- Some pain/discomfort
- Much pain/discomfort
- Strong pain/discomfort
Measured: 3 days
Speech
Measured on a 5-point Likert-scale:
Xerostomia regarding impact on ability to speak:
- Not difficulties
- Insignificant difficulties
- Some difficulties
- Significant difficulties
- Major difficulties
Measured: 3 days
Diurnal variation
Measured on a 5-point Likert-scale:
At what times are xerostomia most pronounced:
- At night
- In the morning
- In the afternoon
- In the evening
- No diurnal difference
Measured: 3 days
Situational dry mouth
Measured on a 3-point Likert-scale:
- By intake of medication
- By worsening of the disease
- In Connection with thirst
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Mar 2018
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The different moisturizers will be compared in a double blind, cross-over design. Patient responses will be collected at baseline, immediately after exposure and after 2 hours.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunhild V Strand, DDS, PhD, Principal investigator, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400969
- Sponsor's protocol ID
- 2016/2316
- Status last verified
- Jan 2018
- First submitted
- 14 Dec 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data will be available by request after publication of effect article.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
- ClinicalTrials.gov ID
- NCT03400969
- Acronym / sponsor ID
- 2016/2316
- Conditions
- Xerostomia
- Keywords
- Palliative, Moisturisers, Dry mouth, Xerostomia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient.
Detailed description
Background:
A majority of patients in palliative care have problems with dry mouth caused by medication or as a direct result of the mortal condition. Dry mouth will cause a variety of problems that commonly affect the disease negatively and contribute to reduced quality of life in the patient's last stage of life. A Cochrane review from 2011 concludes that "there are several moisturising agents available, but no strong evidence that any topical therapy is effective for relieving the symptom of dry mouth." It also concludes that "Oxygenated glycerol triester (OGT) oral spray is more effective than an aqueous electrolyte spray."1
Objectives:
To compare the effectiveness of 3 different oral moisturisers, ; 17 % watery solution of glycerol, OGT oral spray, Aequasyal® and a newly developed product, Salient®.
Methods/design:
30 patients will be recruited from a Norwegian palliative care unit. Eligibility criteria for participants are:
- The patients have xerostomia (subjective feeling of dry mouth). 2
- The patients are palliative and in institutionalized care.
- Curative treatment of existing diseases has been completed.
- WHOs functional status 3/Karnofsky functional status 30 - 40 % (only capable of limited self-care, tied to bed or chair more than 50% of wake time).3, 4
- Participants are cognitively functioning, capable of and willing to consent, capable of giving responses to a limited questionnaire and are expected to remain at the care centre for a minimum of 3 days.
Patients treated with radiotherapy in head and neck region, are excluded from this trial.
The different moisturizers will be compared in a double blind, cross-over design. All patients will be randomized to all three treatments in the cross-over trial, with a minimum of 24 hours wash-out period between the treatments. Patient responses will be collected at baseline, immediately after exposure and after 2 hours. Medical history and medication will be recorded. Primary outcome variables are the subjective feeling of xerostomia, pain/discomfort and speech disturbance.
Ethical considerations:
An application for approval of this study will be sent to the Regional Ethical Committee (REC). There are no known side effects of the agents or methods that will be applied.
Discussion:
To the investigators knowledge, the proposed randomized controlled trial of the effect of three different oral moisturizers will be the first study of this kind to be performed in patients in palliative institutionalized ward. There are no known adverse effects of the products used in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The different moisturizers will be compared in a double blind, cross-over design. Patient responses will be collected at baseline, immediately after exposure and after 2 hours.
| Arm | Type | Receives |
|---|---|---|
| Glycerol 17 % | Active comparator | Device: Glycerol 17%Oral moisturizer |
| Aequasyal (OGT) | Active comparator | Device: Aequasyal (OGT)Oral moisturizer |
| Salient (new product) | Active comparator | Device: Salient (new product)Oral moisturizer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The patients have xerostomia (subjective feeling of dry mouth). 2
- The patients are palliative and in institutionalized care.
- Curative treatment of existing diseases has been completed.
- WHOs functional status 3/Karnofsky functional status 30 - 40 % (only capable of limited self-care, tied to bed or chair more than 50% of wake time).
- Participants are cognitively functioning, capable of and willing to consent, capable of giving responses to a limited questionnaire and are expected to remain at the care centre for a minimum of 3 days.
Key exclusion criteria (2 listed)
- Patients treated with radiotherapy in head and neck region.
- -
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 |
|---|---|---|
| Glycerol 17%Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist. | Device | Glycerol 17 % |
| Aequasyal (OGT)Aequasyl (OGT) will be sprayed on the mucosa, at the end of the oral care procedure, preformed by a dentist. | Device | Aequasyal (OGT) |
| Salient (new product)Salient (new Product) will be applied/given on a spoon, at the end of the oral care procedure, preformed by a dentist. | Device | Salient (new product) |
Primary outcome
Subjective xerostomia
Time frame: 3 days
Measured on a 5-point Likert-scale: Subjective feeling of dry mouth: 1. Not dry 2. Insignificantly dry 3. Fairly dry 4. Almost completely dry 5. Completely dry
4 secondary outcomes
Pain/discomfort
Time frame: 3 days
Speech
Time frame: 3 days
Diurnal variation
Time frame: 3 days
Situational dry mouth
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Individual participant dataSharing planned: Yes. Anonymous data will be available by request after publication of effect article.
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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.
Gunhild V Strand, DDS, PhD principal investigator
University of Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycerol 17%, Aequasyal (OGT) and Salient (new product) in people with Xerostomia, run by University of Bergen at 1 site in Norway.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siri F. Kvalheim, DDS (0047 55586488, Siri.Kvalheim@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective xerostomia (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2018.