Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT03400969
Status:
UNKNOWN
Last Update Posted:
2018-10-29
First Post:
2017-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective xerostomia', 'timeFrame': '3 days', 'description': 'Measured on a 5-point Likert-scale:\n\nSubjective feeling of dry mouth:\n\n1. Not dry\n2. Insignificantly dry\n3. Fairly dry\n4. Almost completely dry\n5. Completely dry'}], 'secondaryOutcomes': [{'measure': 'Pain/discomfort', 'timeFrame': '3 days', 'description': 'Measured on a 5-point Likert-scale:\n\nSubjective feeling pain/discomfort:\n\n1. No pain\n2. Insignificant pain/discomfort\n3. Some pain/discomfort\n4. Much pain/discomfort\n5. Strong pain/discomfort'}, {'measure': 'Speech', 'timeFrame': '3 days', 'description': 'Measured on a 5-point Likert-scale:\n\nXerostomia regarding impact on ability to speak:\n\n1. Not difficulties\n2. Insignificant difficulties\n3. Some difficulties\n4. Significant difficulties\n5. Major difficulties'}, {'measure': 'Diurnal variation', 'timeFrame': '3 days', 'description': 'Measured on a 5-point Likert-scale:\n\nAt what times are xerostomia most pronounced:\n\n1. At night\n2. In the morning\n3. In the afternoon\n4. In the evening\n5. No diurnal difference'}, {'measure': 'Situational dry mouth', 'timeFrame': '3 days', 'description': 'Measured on a 3-point Likert-scale:\n\n1. By intake of medication\n2. By worsening of the disease\n3. In Connection with thirst'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative', 'Moisturisers', 'Dry mouth', 'Xerostomia'], 'conditions': ['Xerostomia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background:\n\nA 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\n\nObjectives:\n\nTo compare the effectiveness of 3 different oral moisturisers, ; 17 % watery solution of glycerol, OGT oral spray, Aequasyal® and a newly developed product, Salient®.\n\nMethods/design:\n\n30 patients will be recruited from a Norwegian palliative care unit. Eligibility criteria for participants are:\n\n1. The patients have xerostomia (subjective feeling of dry mouth). 2\n2. The patients are palliative and in institutionalized care.\n3. Curative treatment of existing diseases has been completed.\n4. 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\n5. 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.\n\nPatients treated with radiotherapy in head and neck region, are excluded from this trial.\n\nThe 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.\n\nEthical considerations:\n\nAn 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.\n\nDiscussion:\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients have xerostomia (subjective feeling of dry mouth). 2\n2. The patients are palliative and in institutionalized care.\n3. Curative treatment of existing diseases has been completed.\n4. 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).\n5. 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.\n\nExclusion Criteria:\n\nPatients treated with radiotherapy in head and neck region.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03400969', 'briefTitle': 'Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'A Randomized Controlled Trial of the Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.', 'orgStudyIdInfo': {'id': '2016/2316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glycerol 17 %', 'description': 'Oral moisturizer', 'interventionNames': ['Device: Glycerol 17%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aequasyal (OGT)', 'description': 'Oral moisturizer', 'interventionNames': ['Device: Aequasyal (OGT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salient (new product)', 'description': 'Oral moisturizer', 'interventionNames': ['Device: Salient (new product)']}], 'interventions': [{'name': 'Glycerol 17%', 'type': 'DEVICE', 'description': 'Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist.', 'armGroupLabels': ['Glycerol 17 %']}, {'name': 'Aequasyal (OGT)', 'type': 'DEVICE', 'description': 'Aequasyl (OGT) will be sprayed on the mucosa, at the end of the oral care procedure, preformed by a dentist.', 'armGroupLabels': ['Aequasyal (OGT)']}, {'name': 'Salient (new product)', 'type': 'DEVICE', 'description': 'Salient (new Product) will be applied/given on a spoon, at the end of the oral care procedure, preformed by a dentist.', 'armGroupLabels': ['Salient (new product)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5099', 'city': 'Bergen', 'state': 'Hordaland', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Signe Solberg', 'role': 'CONTACT', 'email': 'signe.solberg@uib.no', 'phone': '+47 55 58 66 88'}, {'name': 'Anne Åstrøm, PhD', 'role': 'CONTACT', 'email': 'anne.astrom@uib.no', 'phone': '+47 55 58 64 83'}, {'name': 'Stein A Lie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gunhild V Strand, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Siri F Kvalheim, MDS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Einar Berg, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Bergen', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Siri F. Kvalheim, DDS', 'role': 'CONTACT', 'email': 'Siri.Kvalheim@uib.no', 'phone': '0047 55586488'}, {'name': 'Stein-Atle Lie, PhD', 'role': 'CONTACT', 'email': 'Stein.Lie@uib.no', 'phone': '0047 55586477'}], 'overallOfficials': [{'name': 'Gunhild V Strand, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen, Norway'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will be available after publication of article.', 'ipdSharing': 'YES', 'description': 'Anonymous data will be available by request after publication of effect article.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}