Clinical trial NCT06003660: Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT
Official title: BrainFlavor: Brain Neuronal Networks and Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome.

Brief summary: 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.

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.

Primary outcomes:
measure: Olfactory (smell) function
timeFrame: 1 year
measure: Self-reported olfactory (smell) function
timeFrame: 1 year
measure: Gustatory (taste) function
timeFrame: 1 year
measure: Self-reported gustatory (taste) function
timeFrame: 1 year
measure: Oral pain assessment
timeFrame: 1 year
measure: Self-reported oral pain assessment
timeFrame: 1 year
measure: Functional brain connectivity
timeFrame: 1 year
Secondary outcomes:
measure: Measured oral dryness
timeFrame: 1 year
measure: Clinical oral dryness
timeFrame: 1 year
measure: Self-reported oral dryness
timeFrame: 1 year
measure: Oral mucosal status
timeFrame: 1 year
measure: Oral mucositis status
timeFrame: 1 year
measure: Nutritional status
timeFrame: 1 year
measure: Quality of life evaluation
timeFrame: 1 year
measure: Oral health-related quality of life evaluation
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Per Ole Iversen, phd
role: STUDY_DIRECTOR
References: