Hematopoietic Stem Cell TransplantationNCT06003660
Oral, Chemosensory and Trigeminal Functions in Allo-HSCT
An observational study of Hematopoietic Stem Cell Transplantation, run by University of Oslo at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 10 Aug 2023to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome.
Who may be able to join
- patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
University of Oslo
Oslo, Oslo, 0254
Per Ole Iversen, phd, +4722851391, p.o.iversen@medisin.uio.no
Åsmund Rogn, +4795800328, aasmunro@odont.uio.no
About this study
Official title: Oral, Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study
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.
- Conditions
- Hematopoietic Stem Cell Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Adult recipients of allo-HCST. | |
| Controls | Healthy adult subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
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.
Measured: 1 year
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)
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Secondary outcomes (8)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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
Measured: 1 year
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)
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start10 Aug 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Ole Iversen, MD, University of Oslo
- Investigators
- Per Ole Iversen, phd, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003660
- Sponsor's protocol ID
- 282886
- Status last verified
- Apr 2026
- First submitted
- 10 Aug 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral, Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study
- ClinicalTrials.gov ID
- NCT06003660
- Acronym / sponsor ID
- 282886
- Conditions
- Hematopoietic Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Adult recipients of allo-HCST. |
| Controls | – | –Healthy adult subjects |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome.
Key inclusion criteria (1 listed)
- patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Olfactory (smell) function
Time frame: 1 year
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)
Self-reported olfactory (smell) function
Time frame: 1 year
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.
Gustatory (taste) function
Time frame: 1 year
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)
Self-reported gustatory (taste) function
Time frame: 1 year
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.
Oral pain assessment
Time frame: 1 year
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.
Self-reported oral pain assessment
Time frame: 1 year
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.
Functional brain connectivity
Time frame: 1 year
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Per Ole Iversen, phd study director
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per Ole Iversen, phd (+47 22 85 13 91, p.o.iversen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory (smell) function (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.