Xerostomia Clinical Trial
Official title:
A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
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.
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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