Clinical trial NCT02067572: A Randomized Controlled Trial Evaluating the Effectiveness of a Salvia-based Mouthwash in Palliative Care
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Terminal Illness
Xerostomia
Keywords: oral health
mouthwash
salvia
hospice
xerostomia
mouth sores
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2014-02-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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:

1. Does the SO-based mouthwash provide a better treatment than conventional normal saline in maintaining good oral health in terminally ill patients?
2. Is there a difference in the individual perception of oral comfort in patients receiving SO versus patients receiving saline rinsing solution?

Eligibility criteria: 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

Primary outcomes:
measure: Oral health (OMAS)
timeFrame: after 4 days of using mouthwash
measure: Patient's perception of oral comfort
timeFrame: after 4 days of using mouthwash
measure: Oral health (clinical evaluation)
timeFrame: after 4 days of using mouthwash
Secondary outcomes:
measure: General symptom experience
timeFrame: after 4 days of using mouthwash
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Hospice
Study officials:
affiliation: Lovisenberg Diakonale Hospital
name: Anners Lerdal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monsen 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.