Oral, Chemosensory and Trigeminal Functions in Allo-HSCT

Официальное название

Oral, Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study

Обзор

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: * Distortion of taste and smell and trigeminal functions like cooling, tingling, and burning sensations. * Reduced saliva production leading to oral dryness and dental caries. * Changes in the connectivity of the taste-, smell- and pain-cortical brain regions.

Подробное описание

Participants will undergo various tests:

* Smell function assessment with Sniffin' Sticks. * Taste function assessment with Taste Strips. * Oral trigeminal function assessment with von Frey filaments . * Salivary assessment with the Summated Xerostomia Inventory-Dutch questionnaire. * Salivary flow will be measured using salivary flow rate - stimulated whole saliva (SWS). * A clinical oral examination will be done to obtain a Clinical Oral Dryness Score. * Qualitative smell, taste and trigeminal dysfunction will be assessed using a questionnaire. * Radiological and clinical examinations will be performed to evaluate dental and oral mucosal status. * Quality of life using questionnaire. * Nutritional status using questionnaire. * 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.

There will be a comparisons between the patients and healthy controls.

Первичные конечные точки

• Olfactory (smell) function [Срок оценки: 1 year]
• Self-reported olfactory (smell) function [Срок оценки: 1 year]
• Gustatory (taste) function [Срок оценки: 1 year]
• Self-reported gustatory (taste) function [Срок оценки: 1 year]
• Oral pain assessment [Срок оценки: 1 year]
• Self-reported oral pain assessment [Срок оценки: 1 year]
• Functional brain connectivity [Срок оценки: 1 year]

Вторичные конечные точки (8)

• Measured oral dryness [Срок оценки: 1 year]
• Clinical oral dryness [Срок оценки: 1 year]
• Self-reported oral dryness [Срок оценки: 1 year]
• Oral mucosal status [Срок оценки: 1 year]
• Oral mucositis status [Срок оценки: 1 year]
• Nutritional status [Срок оценки: 1 year]
• Quality of life evaluation [Срок оценки: 1 year]
• Oral health-related quality of life evaluation [Срок оценки: 1 year]

Критерии участия

Критерии включения

• patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome

Критерии исключения

• disorders affecting the oral cavity including poor tooth-status
• those using drugs affecting the gustatory/olfactory functions
• those with brain disorders
• those who have a chronic disorder affecting the immune system, have cancer or who are pregnant.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Норвегия · 1 центр

• University of Oslo — Oslo

Идентификаторы

NCT: NCT06003660 · 282886

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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