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Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.

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ClinicalTrials.gov Identifier: NCT03400969
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Bergen

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.

Condition or disease Intervention/treatment Phase
Xerostomia Device: Glycerol 17% Device: Aequasyal (OGT) Device: Salient (new product) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A Block randomisation is made by a person, other than the one who applies the product. Neither the patient nor the person who records the product or the person who registers data knows which product is used for the intervention. The product is not labeled with name
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Subjective xerostomia [ Time Frame: 3 days ]

    Measured on a 5-point Likert-scale:

    Subjective feeling of dry mouth:

    1. Not dry
    2. Insignificantly dry
    3. Fairly dry
    4. Almost completely dry
    5. Completely dry


Secondary Outcome Measures :
  1. Pain/discomfort [ Time Frame: 3 days ]

    Measured on a 5-point Likert-scale:

    Subjective feeling pain/discomfort:

    1. No pain
    2. Insignificant pain/discomfort
    3. Some pain/discomfort
    4. Much pain/discomfort
    5. Strong pain/discomfort

  2. Speech [ Time Frame: 3 days ]

    Measured on a 5-point Likert-scale:

    Xerostomia regarding impact on ability to speak:

    1. Not difficulties
    2. Insignificant difficulties
    3. Some difficulties
    4. Significant difficulties
    5. Major difficulties

  3. Diurnal variation [ Time Frame: 3 days ]

    Measured on a 5-point Likert-scale:

    At what times are xerostomia most pronounced:

    1. At night
    2. In the morning
    3. In the afternoon
    4. In the evening
    5. No diurnal difference

  4. Situational dry mouth [ Time Frame: 3 days ]

    Measured on a 3-point Likert-scale:

    1. By intake of medication
    2. By worsening of the disease
    3. In Connection with thirst



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400969


Contacts
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Contact: Siri F. Kvalheim, DDS 0047 55586488 Siri.Kvalheim@uib.no
Contact: Stein-Atle Lie, PhD 0047 55586477 Stein.Lie@uib.no

Locations
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Norway
University of Bergen Recruiting
Bergen, Hordaland, Norway, 5099
Contact: Signe Solberg    +47 55 58 66 88    signe.solberg@uib.no   
Contact: Anne Åstrøm, PhD    +47 55 58 64 83    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         
Sponsors and Collaborators
University of Bergen
Investigators
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Principal Investigator: Gunhild V Strand, DDS, PhD University of Bergen, Norway

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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT03400969     History of Changes
Other Study ID Numbers: 2016/2316
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous data will be available by request after publication of effect article.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be available after publication of article.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Bergen:
Palliative
Moisturisers
Dry mouth
Xerostomia

Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs