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NCT Number: NCT06003660

Oral, Chemosensory and Trigeminal Functions in Allo-HSCT

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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.

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Measured oral dryness

    Time frame: 1 year

    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.

  2. Clinical oral dryness

    Time frame: 1 year

    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.

  3. Self-reported oral dryness

    Time frame: 1 year

    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.

  4. Oral mucosal status

    Time frame: 1 year

    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

  5. Oral mucositis status

    Time frame: 1 year

    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)

  6. Nutritional status

    Time frame: 1 year

    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.

  7. Quality of life evaluation

    Time frame: 1 year

    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.

  8. Oral health-related quality of life evaluation

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahnoor Nazar, master

CONTACT

[email protected]

+47 97603124

Per Ole Iversen, phd

CONTACT

[email protected]

+47 22 85 13 91

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

Oral, Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 22, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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