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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:
Participants will undergo various tests:
There will be a comparisons between the patients and healthy controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Adult recipients of allo-HCST. | ||
| Controls | Healthy adult subjects |
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| 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. |
| 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 |
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Inclusion Criteria:
• patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome
Exclusion Criteria:
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Patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Per Ole Iversen, phd | University of Oslo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oslo | Recruiting | Oslo | Oslo | 0254 | Norway |
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| 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 |
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 |