Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.

NCT ID: NCT03400969

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-03-15

Brief 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.

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.

Conditions

Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Glycerol 17 %

Oral moisturizer

Group Type: ACTIVE_COMPARATOR

Glycerol 17%

Intervention Type: DEVICE

Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist.

Aequasyal (OGT)

Oral moisturizer

Group Type: ACTIVE_COMPARATOR

Aequasyal (OGT)

Intervention Type: DEVICE

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

Salient (new product)

Oral moisturizer

Group Type: ACTIVE_COMPARATOR

Salient (new product)

Intervention Type: DEVICE

Salient (new Product) will be applied/given on a spoon, at the end of the oral care procedure, preformed by a dentist.

Interventions

Glycerol 17%

Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist.

Intervention Type: DEVICE

Aequasyal (OGT)

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunhild V Strand, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen, Norway

Locations

University of Bergen

Bergen, Hordaland, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Siri F. Kvalheim, DDS

Role: CONTACT

Siri.Kvalheim@uib.no

0047 55586488

Stein-Atle Lie, PhD

Role: CONTACT

Stein.Lie@uib.no

0047 55586477

Facility Contacts

Signe Solberg

Role: primary

signe.solberg@uib.no

+47 55 58 66 88

Anne Åstrøm, PhD

Role: backup

anne.astrom@uib.no

+47 55 58 64 83

Other Identifiers

2016/2316

Identifier Type: -

Identifier Source: org_study_id