ClinicalTrials.gg
RecruitingNCT06003660Updated May 1, 2026

Oral, Chemosensory and Trigeminal Functions in Allo-HSCT

An observational study in Hematopoietic Stem Cell Transplantation, sponsored by University of Oslo. Recruiting at 1 site in Norway. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University of Oslo · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
30 Years to 70 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Hematopoietic Stem Cell Transplantation
03

In context

Lead sponsor

University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients

    Adult recipients of allo-HCST.

  • Controls

    Healthy adult subjects

06

What researchers measure

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 year

  2. 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 year

  3. 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 year

  4. 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 year

  5. Oral pain assessment

    Oral pain perception will be assessed by von Frey filaments. Scores will range from 0 -10 on a visual analogue scale (VAS) where 0 indicates no pain and 10 severe pain.

    Time frame: 1 year

  6. Self-reported oral pain assessment

    Self-reported oral pain will be assessed using a visual analogue scale (VAS) ranging from 0-10 where 0 indicates no oral pain and 10 severe oral pain.

    Time frame: 1 year

  7. Functional brain connectivity

    Functional connectivity analysis (fMRI) of three different networks of interest: (i) the olfactory network (ii) the gustatory, and (iii) the pain matrix. There are no specified quantitative units for these measurements.

    Time frame: 1 year

Secondary 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 year

  2. 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 year

  3. 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 year

  4. 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 year

  5. Oral mucositis status

    Oral mucosal status will be evaluated using the WHO mucositis grading ranging form 0 - 4 where 0 = no oral mucositis, 1 = erythema and soreness, 2 = ulcers, able to eat solids, 3 = ulcers, requires a liquid diet (due to mucositis), 4 = ulcers, alimentation not possible (due to mucositis)

    Time frame: 1 year

  6. Nutritional status

    Nutritional status will be evaluated using the Nutrition Risk Screening 2002 form. Scores range from 0-6. Patients with a score \< 3 is considered to be of no nutritional risk. Patients with a score ≥ 3 is considered to be in nutritional risk.

    Time frame: 1 year

  7. Quality of life evaluation

    Quality of life will be assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores range from 0-100. A high score indicates better quality of life and a low score indicates a worse quality of life.

    Time frame: 1 year

  8. Oral health-related quality of life evaluation

    Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. Scores range from 0-56. A high score indicates worse oral health-related quality of life, while a low score indicates better.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06003660
Lead sponsor
University of Oslo
Responsible party
Per Ole Iversen, MD (Professor, University of Oslo) — Principal investigator
First posted
Aug 22, 2023
Start date
Aug 10, 2023
Primary completion
Dec 30, 2026 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
May 1, 2026

Study contacts

Per Ole Iversen, phd
Contact
p.o.iversen@medisin.uio.no
+47 22 85 13 91
Mahnoor Nazar, master
Contact
Mahnoor.Nazar@odont.uio.no
+47 97603124
Per Ole Iversen, phd
study director · University of Oslo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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