Oral, Chemosensory and Trigeminal Functions in Allo-HSCT

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic Stem Cell Transplantation

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Per Ole Iversen, phd; Phone Number: +47 22 85 13 91; Email: p.o.iversen@medisin.uio.no
• Study Contact Backup: Name: Mahnoor Nazar, master; Phone Number: +47 97603124; Email: Mahnoor.Nazar@odont.uio.no

Study Locations

• Norway
  • Oslo
    • Oslo, Oslo, Norway, 0254
      • Recruiting
      • University of Oslo
      • Contact: Per Ole Iversen, phd; Phone Number: +4722851391; Email: p.o.iversen@medisin.uio.no
      • Contact: Åsmund Rogn; Phone Number: +4795800328; Email: aasmunro@odont.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients; Adult recipients of allo-HCST.
Controls; Healthy adult subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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)	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.	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.	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.	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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)	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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Study Director: Per Ole Iversen, phd, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 282886

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No