Terminal IllnessNCT02067572
A Randomized Controlled Trial Evaluating the Effectiveness of a Salvia-based Mouthwash in Palliative Care
A study testing Saline mouthwash and Salvia mouthwash in people with Terminal Illness and Xerostomia, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
This study examines the effectiveness of an herbal mouthwash made from salvia in maintaining good oral health among patients in palliative care. It is hypothesized that using the mouthwash made from salvia will result in better oral health and more oral comfort than using with conventional normal saline mouthwash. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Illness, Xerostomia
- What is being tested?
- Saline mouthwash and Salvia mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteNorway
- Study dates
- 12 Mar 2014to 8 Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending bedded unit at Hospice
- Over 18 years of age and able to provide written formal consent
- Diagnosed with advanced cancer
- Patient with positive response when asked if they experience oral discomfort or complications.
Who cannot join
- Estimated life expectancy prognosis of less than 2 weeks
- Significant cognitive impairment
- Current use of antifungal medication
- Currently receiving radiation therapy or chemotherapy
- Epileptic
- Diabetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Effectiveness of Normal Saline Mouthwash and Mouthwash Based on Tea Solution From Salvia Officinalis (SO) in Palliative Care. A Randomized Controlled Trial
This study examines the effectiveness of an herbal mouthwash made from salvia in maintaining good oral health among patients in palliative care. It is hypothesized that using the mouthwash made from salvia will result in better oral health and more oral comfort than using with conventional normal saline mouthwash.
Read the detailed description
The aim of this study is to examine the effectiveness of an herbal mouthwash made from salvia officinalis (SO) in maintaining good oral health among patients in palliative care. The study compares a mouthwash based on salvia tea solution with conventional normal saline mouthwash and addresses the following research questions:
- Does the SO-based mouthwash provide a better treatment than conventional normal saline in maintaining good oral health in terminally ill patients?
- Is there a difference in the individual perception of oral comfort in patients receiving SO versus patients receiving saline rinsing solution?
- Conditions
- Terminal Illness, Xerostomia
- Being tested
- Saline mouthwash, Salvia mouthwash
- Keywords
- oral health, mouthwash, salvia, hospice, xerostomia, mouth sores
- Medical subject headings
- Xerostomia, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline mouthwashOther
Salvia mouthwashOther
| Study group | Role | What they receive |
|---|---|---|
| Salvia | Experimental | Salvia mouthwash used 4 times per day for 4 days Receives: Other: Salvia mouthwash |
| Saline | Active comparator | Saline mouthwash used 4 times per day for 4 days. Receives: Other: Saline mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health (OMAS)
Oral Mucositis Assessment Scale (OMAS)
Measured: after 4 days of using mouthwash
Patient's perception of oral comfort
Questions regarding oral discomfort and EORTC-OH17
Measured: after 4 days of using mouthwash
Oral health (clinical evaluation)
Clinical evaluation by dentist
Measured: after 4 days of using mouthwash
Secondary outcomes (1)
General symptom experience
Edmonton Symptom Assessment System (ESAS)
Measured: after 4 days of using mouthwash
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study start12 Mar 2014
- Primary completion8 Sep 2016
- Study completion8 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Terminal IllnessStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Anners Lerdal, PhD, Principal investigator, Lovisenberg Diakonale Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067572
- Sponsor's protocol ID
- Salvia
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2014
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monsen RE, Kristoffersen AK, Gay CL, Herlofson BB, Fjeld KG, Hove LH, Nordgarden H, Tollisen A, Lerdal A, Enersen M. Identification and susceptibility testing of oral candidiasis in advanced cancer patients. BMC Oral Health. 2023 Apr 18;23(1):223. doi: 10.1186/s12903-023-02950-y.
PubMed 37072843Monsen RE, Herlofson BB, Gay C, Fjeld KG, Hove LH, Malterud KE, Saghaug E, Slaaen J, Sundal T, Tollisen A, Lerdal A. A mouth rinse based on a tea solution of Salvia officinalis for oral discomfort in palliative cancer care: a randomized controlled trial. Support Care Cancer. 2021 Sep;29(9):4997-5007. doi: 10.1007/s00520-021-06021-2. Epub 2021 Feb 14.
PubMed 33586003
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Normal Saline Mouthwash and Mouthwash Based on Tea Solution From Salvia Officinalis (SO) in Palliative Care. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02067572
- Acronym / sponsor ID
- Salvia
- Conditions
- Terminal Illness, Xerostomia
- Keywords
- oral health, mouthwash, salvia, hospice, xerostomia, mouth sores
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 12 Mar 2014 (actual)
- Primary completion
- 8 Sep 2016 (actual)
- Study completion
- 8 Sep 2016 (actual)
- First posted
- 20 Feb 2014 (estimated)
- 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 examines the effectiveness of an herbal mouthwash made from salvia in maintaining good oral health among patients in palliative care. It is hypothesized that using the mouthwash made from salvia will result in better oral health and more oral comfort than using with conventional normal saline mouthwash.
Detailed description
The aim of this study is to examine the effectiveness of an herbal mouthwash made from salvia officinalis (SO) in maintaining good oral health among patients in palliative care. The study compares a mouthwash based on salvia tea solution with conventional normal saline mouthwash and addresses the following research questions:
- Does the SO-based mouthwash provide a better treatment than conventional normal saline in maintaining good oral health in terminally ill patients?
- Is there a difference in the individual perception of oral comfort in patients receiving SO versus patients receiving saline rinsing solution?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvia | Experimental | Other: Salvia mouthwashSalvia mouthwash used 4 times per day for 4 days |
| Saline | Active comparator | Other: Saline mouthwashSaline mouthwash used 4 times per day for 4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Attending bedded unit at Hospice
- Over 18 years of age and able to provide written formal consent
- Diagnosed with advanced cancer
- Patient with positive response when asked if they experience oral discomfort or complications.
Key exclusion criteria (6 listed)
- Estimated life expectancy prognosis of less than 2 weeks
- Significant cognitive impairment
- Current use of antifungal medication
- Currently receiving radiation therapy or chemotherapy
- Epileptic
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 |
|---|---|---|
| Saline mouthwash | Other | Saline |
| Salvia mouthwash | Other | Salvia |
Primary outcome
Oral health (OMAS)
Time frame: after 4 days of using mouthwash
Oral Mucositis Assessment Scale (OMAS)
Patient's perception of oral comfort
Time frame: after 4 days of using mouthwash
Questions regarding oral discomfort and EORTC-OH17
Oral health (clinical evaluation)
Time frame: after 4 days of using mouthwash
Clinical evaluation by dentist
1 secondary outcome
General symptom experience
Time frame: after 4 days of using mouthwash
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Derived from this study: PubMed 37072843Monsen RE, Kristoffersen AK, Gay CL, Herlofson BB, Fjeld KG, Hove LH, Nordgarden H, Tollisen A, Lerdal A, Enersen M. Identification and susceptibility testing of oral candidiasis in advanced cancer patients. BMC Oral Health. 2023 Apr 18;23(1):223. doi: 10.1186/s12903-023-02950-y.
- Derived from this study: PubMed 33586003Monsen RE, Herlofson BB, Gay C, Fjeld KG, Hove LH, Malterud KE, Saghaug E, Slaaen J, Sundal T, Tollisen A, Lerdal A. A mouth rinse based on a tea solution of Salvia officinalis for oral discomfort in palliative cancer care: a randomized controlled trial. Support Care Cancer. 2021 Sep;29(9):4997-5007. doi: 10.1007/s00520-021-06021-2. Epub 2021 Feb 14.
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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.
Anners Lerdal, PhD principal investigator
Lovisenberg Diakonale Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline mouthwash and Salvia mouthwash in people with Terminal Illness and Xerostomia, run by Lovisenberg Diakonale Hospital 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 4 inclusion and 6 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 20 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 health (OMAS) (time frame: after 4 days of using mouthwash). The study lists 3 primary outcomes in all. 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 NCT02067572, which also lists 2 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 20 Feb 2017.