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

Not Applicable

Completed

• Conditions: Terminal Illness; Xerostomia
• Interventions: Other: Salvia mouthwash; Other: Saline mouthwash

• Registration Number: NCT02067572
• Lead Sponsor: Lovisenberg Diakonale Hospital

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?

Study Timeline

• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-20
• Study Start: 2014-03-12
• Primary Completion: 2016-09-08
• Study Completion: 2016-09-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salvia	Salvia mouthwash	Salvia mouthwash used 4 times per day for 4 days
Saline	Saline mouthwash	Saline mouthwash used 4 times per day for 4 days.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
General symptom experience	after 4 days of using mouthwash	Edmonton Symptom Assessment System (ESAS)

Trial Locations

Locations (1)

Lovisenberg Hospice; 🇳🇴 Oslo, Norway