Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.

A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.

This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient.

Study Overview

• Status: Unknown
• Conditions: Xerostomia
• Intervention / Treatment: Device: Glycerol 17%; Device: Aequasyal (OGT); Device: Salient (new product)

Detailed Description

Background:

A majority of patients in palliative care have problems with dry mouth caused by medication or as a direct result of the mortal condition. Dry mouth will cause a variety of problems that commonly affect the disease negatively and contribute to reduced quality of life in the patient's last stage of life. A Cochrane review from 2011 concludes that "there are several moisturising agents available, but no strong evidence that any topical therapy is effective for relieving the symptom of dry mouth." It also concludes that "Oxygenated glycerol triester (OGT) oral spray is more effective than an aqueous electrolyte spray."1

Objectives:

To compare the effectiveness of 3 different oral moisturisers, ; 17 % watery solution of glycerol, OGT oral spray, Aequasyal® and a newly developed product, Salient®.

Methods/design:

30 patients will be recruited from a Norwegian palliative care unit. Eligibility criteria for participants are:

1. The patients have xerostomia (subjective feeling of dry mouth). 2
2. The patients are palliative and in institutionalized care.
3. Curative treatment of existing diseases has been completed.
4. WHOs functional status 3/Karnofsky functional status 30 - 40 % (only capable of limited self-care, tied to bed or chair more than 50% of wake time).3, 4
5. Participants are cognitively functioning, capable of and willing to consent, capable of giving responses to a limited questionnaire and are expected to remain at the care centre for a minimum of 3 days.

Patients treated with radiotherapy in head and neck region, are excluded from this trial.

The different moisturizers will be compared in a double blind, cross-over design. All patients will be randomized to all three treatments in the cross-over trial, with a minimum of 24 hours wash-out period between the treatments. Patient responses will be collected at baseline, immediately after exposure and after 2 hours. Medical history and medication will be recorded. Primary outcome variables are the subjective feeling of xerostomia, pain/discomfort and speech disturbance.

Ethical considerations:

An application for approval of this study will be sent to the Regional Ethical Committee (REC). There are no known side effects of the agents or methods that will be applied.

Discussion:

To the investigators knowledge, the proposed randomized controlled trial of the effect of three different oral moisturizers will be the first study of this kind to be performed in patients in palliative institutionalized ward. There are no known adverse effects of the products used in this study.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5099
      • Recruiting
      • University of Bergen
      • Contact: Signe Solberg; Phone Number: +47 55 58 66 88; Email: signe.solberg@uib.no
      • Contact: Anne Åstrøm, PhD; Phone Number: +47 55 58 64 83; Email: anne.astrom@uib.no
      • Principal Investigator: Stein A Lie, PhD
      • Sub-Investigator: Gunhild V Strand, PhD
      • Sub-Investigator: Siri F Kvalheim, MDS
      • Sub-Investigator: Einar Berg, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patients have xerostomia (subjective feeling of dry mouth). 2
2. The patients are palliative and in institutionalized care.
3. Curative treatment of existing diseases has been completed.
4. WHOs functional status 3/Karnofsky functional status 30 - 40 % (only capable of limited self-care, tied to bed or chair more than 50% of wake time).
5. Participants are cognitively functioning, capable of and willing to consent, capable of giving responses to a limited questionnaire and are expected to remain at the care centre for a minimum of 3 days.

Exclusion Criteria:

Patients treated with radiotherapy in head and neck region.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glycerol 17 %; Oral moisturizer	Device: Glycerol 17%; Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist.
Active Comparator: Aequasyal (OGT); Oral moisturizer	Device: Aequasyal (OGT); Aequasyl (OGT) will be sprayed on the mucosa, at the end of the oral care procedure, preformed by a dentist.
Active Comparator: Salient (new product); Oral moisturizer	Device: Salient (new product); Salient (new Product) will be applied/given on a spoon, at the end of the oral care procedure, preformed by a dentist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective xerostomia	Measured on a 5-point Likert-scale: Subjective feeling of dry mouth: Not dry; Insignificantly dry; Fairly dry; Almost completely dry; Completely dry	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain/discomfort	Measured on a 5-point Likert-scale: Subjective feeling pain/discomfort: No pain; Insignificant pain/discomfort; Some pain/discomfort; Much pain/discomfort; Strong pain/discomfort	3 days
Speech	Measured on a 5-point Likert-scale: Xerostomia regarding impact on ability to speak: Not difficulties; Insignificant difficulties; Some difficulties; Significant difficulties; Major difficulties	3 days
Diurnal variation	Measured on a 5-point Likert-scale: At what times are xerostomia most pronounced: At night; In the morning; In the afternoon; In the evening; No diurnal difference	3 days
Situational dry mouth	Measured on a 3-point Likert-scale: By intake of medication; By worsening of the disease; In Connection with thirst	3 days

Collaborators and Investigators

• Sponsor: University of Bergen
• Investigators: Principal Investigator: Gunhild V Strand, DDS, PhD, University of Bergen, Norway

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): March 15, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Xerostomia; Dry mouth; Palliative; Moisturisers
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia; Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: 2016/2316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymous data will be available by request after publication of effect article.
• IPD Sharing Time Frame: Data will be available after publication of article.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No