NCT02067572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

March 12, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2016

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

February 18, 2014

Last Update Submit

February 17, 2017

Conditions

Terminal IllnessXerostomia

Keywords

oral healthmouthwashsalviahospicexerostomiamouth sores

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • General symptom experience

    after 4 days of using mouthwash

Study Arms (2)

Salvia

EXPERIMENTAL

Salvia mouthwash used 4 times per day for 4 days

Other: Salvia mouthwash

Saline

ACTIVE COMPARATOR

Saline mouthwash used 4 times per day for 4 days.

Other: Saline mouthwash

Interventions

Saline mouthwashOTHER
Saline
Salvia mouthwashOTHER
Salvia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Hospice

Oslo, 0440, Norway

Location

Related Publications (2)

  • 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.

    PMID: 37072843DERIVED

  • 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.

    PMID: 33586003DERIVED

MeSH Terms

Conditions

XerostomiaOral Ulcer

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Anners Lerdal, PhD

    Lovisenberg Diakonale Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 20, 2014

Study Start

March 12, 2014

Primary Completion

September 8, 2016

Study Completion

September 8, 2016

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

NO(1)