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

Primary Purpose

Terminal Illness, Xerostomia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Saline mouthwash
Salvia mouthwash
Sponsored by
Lovisenberg Diakonale Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Terminal Illness focused on measuring oral health, mouthwash, salvia, hospice, xerostomia, mouth sores

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lovisenberg Hospice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Salvia

Saline

Arm Description

Salvia mouthwash used 4 times per day for 4 days

Saline mouthwash used 4 times per day for 4 days.

Outcomes

Primary Outcome Measures

Oral health (OMAS)
Oral Mucositis Assessment Scale (OMAS)
Patient's perception of oral comfort
Questions regarding oral discomfort and EORTC-OH17
Oral health (clinical evaluation)
Clinical evaluation by dentist

Secondary Outcome Measures

General symptom experience
Edmonton Symptom Assessment System (ESAS)

Full Information

First Posted
February 18, 2014
Last Updated
February 17, 2017
Sponsor
Lovisenberg Diakonale Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT02067572
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 12, 2014 (Actual)
Primary Completion Date
September 8, 2016 (Actual)
Study Completion Date
September 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lovisenberg Diakonale Hospital
Collaborators
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Terminal Illness, Xerostomia
Keywords
oral health, mouthwash, salvia, hospice, xerostomia, mouth sores

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salvia
Arm Type
Experimental
Arm Description
Salvia mouthwash used 4 times per day for 4 days
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
Saline mouthwash used 4 times per day for 4 days.
Intervention Type
Other
Intervention Name(s)
Saline mouthwash
Intervention Type
Other
Intervention Name(s)
Salvia mouthwash
Primary Outcome Measure Information:
Title
Oral health (OMAS)
Description
Oral Mucositis Assessment Scale (OMAS)
Time Frame
after 4 days of using mouthwash
Title
Patient's perception of oral comfort
Description
Questions regarding oral discomfort and EORTC-OH17
Time Frame
after 4 days of using mouthwash
Title
Oral health (clinical evaluation)
Description
Clinical evaluation by dentist
Time Frame
after 4 days of using mouthwash
Secondary Outcome Measure Information:
Title
General symptom experience
Description
Edmonton Symptom Assessment System (ESAS)
Time Frame
after 4 days of using mouthwash

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anners Lerdal, PhD
Organizational Affiliation
Lovisenberg Diakonale Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lovisenberg Hospice
City
Oslo
ZIP/Postal Code
0440
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
33586003
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.
Results Reference
derived

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

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