Oral, Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Olfactory (smell) function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome
排除标准
- •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.
研究组 & 干预措施
Patients
Adult recipients of allo-HCST.
Controls
Healthy adult subjects
结局指标
主要结局
Olfactory (smell) function
时间窗: 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)
Self-reported olfactory (smell) function
时间窗: 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.
Functional brain connectivity
时间窗: 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.
Gustatory (taste) function
时间窗: 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)
Self-reported gustatory (taste) function
时间窗: 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.
Oral pain assessment
时间窗: 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.
Self-reported oral pain assessment
时间窗: 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.
次要结局
- Self-reported oral dryness(1 year)
- Oral mucosal status(1 year)
- Quality of life evaluation(1 year)
- Nutritional status(1 year)
- Measured oral dryness(1 year)
- Clinical oral dryness(1 year)
- Oral health-related quality of life evaluation(1 year)
- Oral mucositis status(1 year)
研究者
Per Ole Iversen, MD
Professor
University of Oslo