Oral, Chemosensory and Trigeminal Functions in Allo-HSCT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-70
SponsorUniversity of Oslo
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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 population
Patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 2 trial groupsGroup A: Patients
Group B: Controls
Trial outcomes
Primary outcomes
1
Olfactory (smell) function
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)
Time frame
1 year2
Self-reported olfactory (smell) function
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.
Time frame
1 year3
Gustatory (taste) function
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)
Time frame
1 year4
Self-reported gustatory (taste) function
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.
Time frame
1 yearSecondary outcomes
1
Measured oral dryness
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.
Time frame
1 year2
Clinical oral dryness
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.
Time frame
1 year3
Self-reported oral dryness
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.
Time frame
1 year4
Oral mucosal status
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
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov