University of Oslo
Oslo, 0254, Norway
Location status: Recruiting
Location contact
Per Ole Iversen, phd
CONTACT
Åsmund Rogn
CONTACT
NCT Number: NCT06003660
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.
Interested in participating?
Request Info30 year–70 year
All sexes
Observational
Oslo, 0254, Norway
Location status: Recruiting
Per Ole Iversen, phd
CONTACT
Åsmund Rogn
CONTACT
Participants will undergo various tests:
There will be a comparisons between the patients and healthy controls.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
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)
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.
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.
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.
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.
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.
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.
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.
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
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)
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Mahnoor Nazar, master
CONTACT
Per Ole Iversen, phd
CONTACT
University of Oslo
Other
Oral, Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study
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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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