Oral, Chemosensory and Trigeminal Functions in Allo-HSCT

NCT06003660 | Recruiting

• 1 other identifier: 282886
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Measured oral dryness

  1 year

• Clinical oral dryness

  1 year

• Self-reported oral dryness

  1 year

• Oral mucosal status

  1 year

• Oral mucositis status

  1 year

Study Arms (2)

Patients

Adult recipients of allo-HCST.

Controls

Healthy adult subjects

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

University of Oslo

Oslo, Oslo, 0254, Norway

RECRUITING

Study Officials

• Per Ole Iversen, phd

  University of Oslo

  STUDY DIRECTOR

Central Study Contacts

Per Ole Iversen, phd

CONTACT

+47 22 85 13 91; p.o.iversen@medisin.uio.no

Mahnoor Nazar, master

CONTACT

+47 97603124; Mahnoor.Nazar@odont.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 22, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

NO (1)