A Randomized Controlled Trial Evaluating the Effectiveness of a Salvia-based Mouthwash in Palliative Care

Study Overview
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Brief Summary
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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
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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?

Official Title
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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

Conditions
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Terminal Illness, Xerostomia

Intervention / Treatment
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* Other: Saline mouthwash
* Other: Salvia mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salvia<br>Salvia mouthwash used 4 times per day for 4 days | Other: Salvia mouthwash<br> <br> |
| Active Comparator: Saline<br>Saline mouthwash used 4 times per day for 4 days. | Other: Saline mouthwash<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health (OMAS) | Oral Mucositis Assessment Scale (OMAS) | after 4 days of using mouthwash | 
| Patient's perception of oral comfort | Questions regarding oral discomfort and EORTC-OH17 | after 4 days of using mouthwash | 
| Oral health (clinical evaluation) | Clinical evaluation by dentist | after 4 days of using mouthwash | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General symptom experience | Edmonton Symptom Assessment System (ESAS) | after 4 days of using mouthwash | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral health, mouthwash, salvia, hospice, xerostomia, mouth sores