A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Bergen
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Subjective xerostomia
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- 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
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Glycerol 17 %
Oral moisturizer
Intervention: Glycerol 17% (Device)
Aequasyal (OGT)
Oral moisturizer
Intervention: Aequasyal (OGT) (Device)
Salient (new product)
Oral moisturizer
Intervention: Salient (new product) (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Speech(3 days)
- Pain/discomfort(3 days)
- Diurnal variation(3 days)
- Situational dry mouth(3 days)