Clinical trial NCT03400969: Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
Official title: A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Xerostomia
Keywords: Palliative
Moisturisers
Dry mouth
Xerostomia
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

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Primary outcomes:
measure: Subjective xerostomia
timeFrame: 3 days
Secondary outcomes:
measure: Pain/discomfort
timeFrame: 3 days
measure: Speech
timeFrame: 3 days
measure: Diurnal variation
timeFrame: 3 days
measure: Situational dry mouth
timeFrame: 3 days
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
Study officials:
affiliation: University of Bergen, Norway
name: Gunhild V Strand, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: