Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.

Study Overview
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Brief Summary
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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
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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: The patients have xerostomia (subjective feeling of dry mouth). 2 The patients are palliative and in institutionalized care. Curative treatment of existing diseases has been completed. 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 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.

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

Conditions
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Xerostomia

Intervention / Treatment
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* Device: Glycerol 17%
* Device: Aequasyal (OGT)
* Device: Salient (new product)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients have xerostomia (subjective feeling of dry mouth). 2 The patients are palliative and in institutionalized care. Curative treatment of existing diseases has been completed. 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). 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. -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The different moisturizers will be compared in a double blind, cross-over design. Patient responses will be collected at baseline, immediately after exposure and after 2 hours.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative, Moisturisers, Dry mouth, Xerostomia