Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-02 @ 8:31 AM
Study NCT ID:
NCT06003660
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2023-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Olfactory (smell) function', 'timeFrame': '1 year', 'description': "Odour pens of the Sniffin' Sticks (Burghart Messtechnik, Wedel, Germany) will be used to test olfactory function (TDI). Scores will range from 0 - 48 where score ≤ 16.5 = anosmia (no sense of smell), score 16.6 - 30.5 = hyposmia (reduced sense of smell) and score \\>30.5 = normosmia (normal sense of smell)"}, {'measure': 'Self-reported olfactory (smell) function', 'timeFrame': '1 year', 'description': 'Self-reported smell function will be assessed using a visual analogue scale (VAS) ranging from 0-10 where 0 indicates no smell function and 10 very good smell function.'}, {'measure': 'Gustatory (taste) function', 'timeFrame': '1 year', 'description': 'Taste function will be evaluated by using taste strips ("Taste Strips "Burghart Messtechnik, Wedel, Germany) with four basic taste qualities (sweet, sour, salty and bitter) in 4 different concentrations each. Scores will range from 0 - 16 where 0 = ageusia (no sense of taste), 1 - 9 = hypogeusia (reduced sense of smell) and 10 - 16 = normogeusia (normal sense of taste)'}, {'measure': 'Self-reported gustatory (taste) function', 'timeFrame': '1 year', 'description': 'Self-reported taste function will be assessed using a visual analogue scale (VAS) ranging from 0-10 where 0 indicates no taste function and 10 very good taste function.'}, {'measure': 'Oral pain assessment', 'timeFrame': '1 year', 'description': 'Oral pain perception will be assessed by von Frey filaments. Scores will range from 0 -10 on a visual analogue scale (VAS) where 0 indicates no pain and 10 severe pain.'}, {'measure': 'Self-reported oral pain assessment', 'timeFrame': '1 year', 'description': 'Self-reported oral pain will be assessed using a visual analogue scale (VAS) ranging from 0-10 where 0 indicates no oral pain and 10 severe oral pain.'}, {'measure': 'Functional brain connectivity', 'timeFrame': '1 year', 'description': 'Functional connectivity analysis (fMRI) of three different networks of interest: (i) the olfactory network (ii) the gustatory, and (iii) the pain matrix. There are no specified quantitative units for these measurements.'}], 'secondaryOutcomes': [{'measure': 'Measured oral dryness', 'timeFrame': '1 year', 'description': 'Saliva production will be measured using salivary flow rate - stimulated whole saliva (SWS). Hyposalivation is defined as a salivary secretion rate of ≤0.7 mL/min for SWS.'}, {'measure': 'Clinical oral dryness', 'timeFrame': '1 year', 'description': 'Clinical oral dryness will be assessed using Clinical Oral Dryness Score (CODS). Scores will range from 0 to 10 points. Score 1-3 is considered mild oral dryness, 4-6 moderate and 7-10 severe oral dryness.'}, {'measure': 'Self-reported oral dryness', 'timeFrame': '1 year', 'description': 'Self-reported oral dryness will be assessed using the Xerostomia Inventory (XI) questionnaire. Scores will range from 11 to 55 points, with values \\<14 considered as normal.'}, {'measure': 'Oral mucosal status', 'timeFrame': '1 year', 'description': 'Oral mucosal status will be evaluated using mucosal-plaque index (MPS). Scores will range from 2 - 8 where 2 - 4 = good/acceptable, 5 - 6 = no acceptable and 7 - 8 = poor status'}, {'measure': 'Oral mucositis status', 'timeFrame': '1 year', 'description': 'Oral mucosal status will be evaluated using the WHO mucositis grading ranging form 0 - 4 where 0 = no oral mucositis, 1 = erythema and soreness, 2 = ulcers, able to eat solids, 3 = ulcers, requires a liquid diet (due to mucositis), 4 = ulcers, alimentation not possible (due to mucositis)'}, {'measure': 'Nutritional status', 'timeFrame': '1 year', 'description': 'Nutritional status will be evaluated using the Nutrition Risk Screening 2002 form. Scores range from 0-6. Patients with a score \\< 3 is considered to be of no nutritional risk. Patients with a score ≥ 3 is considered to be in nutritional risk.'}, {'measure': 'Quality of life evaluation', 'timeFrame': '1 year', 'description': 'Quality of life will be assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores range from 0-100. A high score indicates better quality of life and a low score indicates a worse quality of life.'}, {'measure': 'Oral health-related quality of life evaluation', 'timeFrame': '1 year', 'description': 'Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. Scores range from 0-56. A high score indicates worse oral health-related quality of life, while a low score indicates better.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, cohort study is to learn about smell, taste and trigeminal dysfunction in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). The research team hypothesizes that treatment with allo-HSCT will induce:\n\n* Distortion of taste and smell and trigeminal functions like cooling, tingling, and burning sensations.\n* Reduced saliva production leading to oral dryness and dental caries.\n* Changes in the connectivity of the taste-, smell- and pain-cortical brain regions.', 'detailedDescription': "Participants will undergo various tests:\n\n* Smell function assessment with Sniffin' Sticks.\n* Taste function assessment with Taste Strips.\n* Oral trigeminal function assessment with von Frey filaments .\n* Salivary assessment with the Summated Xerostomia Inventory-Dutch questionnaire.\n* Salivary flow will be measured using salivary flow rate - stimulated whole saliva (SWS).\n* A clinical oral examination will be done to obtain a Clinical Oral Dryness Score.\n* Qualitative smell, taste and trigeminal dysfunction will be assessed using a questionnaire.\n* Radiological and clinical examinations will be performed to evaluate dental and oral mucosal status.\n* Quality of life using questionnaire.\n* Nutritional status using questionnaire.\n* Magnetic resonance imaging of the brain will be taken to capture regions-of-interest for the three different networks of interest; (i) the gustatory network reflecting changes in taste perception, (ii) the olfactory network, related to the changes in smell, and (iii) the pain matrix reflecting pain.\n\nThere will be a comparisons between the patients and healthy controls."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome\n\nExclusion Criteria:\n\n* disorders affecting the oral cavity including poor tooth-status\n* those using drugs affecting the gustatory/olfactory functions\n* those with brain disorders\n* those who have a chronic disorder affecting the immune system, have cancer or who are pregnant.'}, 'identificationModule': {'nctId': 'NCT06003660', 'briefTitle': 'Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'BrainFlavor: Brain Neuronal Networks and Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study', 'orgStudyIdInfo': {'id': '282886'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Adult recipients of allo-HCST.'}, {'label': 'Controls', 'description': 'Healthy adult subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0254', 'city': 'Oslo', 'state': 'Oslo County', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Per Ole Iversen, phd', 'role': 'CONTACT', 'email': 'p.o.iversen@medisin.uio.no', 'phone': '+4722851391'}, {'name': 'Åsmund Rogn', 'role': 'CONTACT', 'email': 'aasmunro@odont.uio.no', 'phone': '+4795800328'}], 'facility': 'University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Per Ole Iversen, phd', 'role': 'CONTACT', 'email': 'p.o.iversen@medisin.uio.no', 'phone': '+47 22 85 13 91'}, {'name': 'Åsmund Rogn, master', 'role': 'CONTACT', 'email': 'asmund.rogn@odont.uio.no', 'phone': '+47 958 00 328'}], 'overallOfficials': [{'name': 'Per Ole Iversen, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Per Ole Iversen, MD', 'investigatorAffiliation': 'University of Oslo'}}}}