Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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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Contacts and Locations

Contacts

Contact: Siri F. Kvalheim, DDS; 0047 55586488; Siri.Kvalheim@uib.no

Contact: Stein-Atle Lie, PhD; 0047 55586477; Stein.Lie@uib.no

Locations

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

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

More Information

• Responsible Party: University of Bergen
• ClinicalTrials.gov Identifier: NCT03400969
• Other Study ID Numbers: 2016/2316
• First Posted: January 17, 2018
• 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.

• 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:

Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Glycerol; Cryoprotective Agents; Protective Agents; Physiological Effects of Drugs