Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03400969
Status:
UNKNOWN
Last Update Posted:
2018-10-29
First Post:
2017-12-14
Brief Title:
Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients
Sponsor:
University of Bergen
Organization:
University of Bergen
Study Overview
Official Title:
A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 spray1
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
Methodsdesign
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 3Karnofsky functional status 30 - 40 only capable of limited self-care tied to bed or chair more than 50 of wake time3 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 paindiscomfort 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
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 patients 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 spray1
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
Methodsdesign
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 3Karnofsky functional status 30 - 40 only capable of limited self-care tied to bed or chair more than 50 of wake time3 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 paindiscomfort 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None