Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400969
• Other study ID #: 2016/2316
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: January 2018
• Source: University of Bergen
• Contact: Siri F. Kvalheim, DDS
• Phone: 0047 55586488
• Email: Siri.Kvalheim[@]uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 15, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Xerostomia

Intervention

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.
• Aequasyal (OGT)
Aequasyl (OGT) will be sprayed on the mucosa, at the end of the oral care procedure, preformed by a dentist.
• 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.

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen	Hordaland

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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