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Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT

U

University of Oslo

Status

Enrolling

Conditions

Hematopoietic Stem Cell Transplantation

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

70 participants in 2 patient groups

Patients
Description:
Adult recipients of allo-HCST.
Controls
Description:
Healthy adult subjects

Trial contacts and locations

1

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Central trial contact

Åsmund Rogn, master; Per Ole Iversen, phd

Data sourced from clinicaltrials.gov

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