Oral, Chemosensory and Trigeminal Functions in Allo-HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hematopoietic Stem Cell Transplantation. Basic parameters: 30 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oral, Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study
Overview
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.
Detailed description
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.
Primary outcome measures
- Olfactory (smell) function [Time frame: 1 year]
- Self-reported olfactory (smell) function [Time frame: 1 year]
- Gustatory (taste) function [Time frame: 1 year]
- Self-reported gustatory (taste) function [Time frame: 1 year]
- Oral pain assessment [Time frame: 1 year]
- Self-reported oral pain assessment [Time frame: 1 year]
- Functional brain connectivity [Time frame: 1 year]
Secondary outcome measures (8)
- Measured oral dryness [Time frame: 1 year]
- Clinical oral dryness [Time frame: 1 year]
- Self-reported oral dryness [Time frame: 1 year]
- Oral mucosal status [Time frame: 1 year]
- Oral mucositis status [Time frame: 1 year]
- Nutritional status [Time frame: 1 year]
- Quality of life evaluation [Time frame: 1 year]
- Oral health-related quality of life evaluation [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- University of Oslo — Oslo
Identifiers
NCT: NCT06003660 · 282886