xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06003660</url>
    </required_header>
    <id_info>
      <org_study_id>282886</org_study_id>
      <nct_id>NCT06003660</nct_id>
    </id_info>
    <brief_title>Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT</brief_title>
    <official_title>BrainFlavor: Brain Neuronal Networks and Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oslo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oslo</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this prospective, cohort study is to learn about smell, taste and trigeminal&#xD;
        dysfunction in patients receiving allogeneic hematopoietic stem cell transplantation&#xD;
        (allo-HSCT). The research team hypothesizes that treatment with allo-HSCT will induce:&#xD;
  &#xD;
          -  Distortion of taste and smell and trigeminal functions like cooling, tingling, and&#xD;
             burning sensations.&#xD;
  &#xD;
          -  Reduced saliva production leading to oral dryness and dental caries.&#xD;
  &#xD;
          -  Changes in the connectivity of the taste-, smell- and pain-cortical brain regions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will undergo various tests:&#xD;
  &#xD;
          -  Smell function assessment with Sniffin' Sticks.&#xD;
  &#xD;
          -  Taste function assessment with Taste Strips.&#xD;
  &#xD;
          -  Oral trigeminal function assessment with von Frey filaments .&#xD;
  &#xD;
          -  Salivary assessment with the Summated Xerostomia Inventory-Dutch questionnaire.&#xD;
  &#xD;
          -  Salivary flow will be measured using salivary flow rate - stimulated whole saliva (SWS).&#xD;
  &#xD;
          -  A clinical oral examination will be done to obtain a Clinical Oral Dryness Score.&#xD;
  &#xD;
          -  Qualitative smell, taste and trigeminal dysfunction will be assessed using a&#xD;
             questionnaire.&#xD;
  &#xD;
          -  Radiological and clinical examinations will be performed to evaluate dental and oral&#xD;
             mucosal status.&#xD;
  &#xD;
          -  Quality of life using questionnaire.&#xD;
  &#xD;
          -  Nutritional status using questionnaire.&#xD;
  &#xD;
          -  Magnetic resonance imaging of the brain will be taken to capture regions-of-interest for&#xD;
             the three different networks of interest; (i) the gustatory network reflecting changes&#xD;
             in taste perception, (ii) the olfactory network, related to the changes in smell, and&#xD;
             (iii) the pain matrix reflecting pain.&#xD;
  &#xD;
        There will be a comparisons between the patients and healthy controls.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Olfactory (smell) function</measure>
      <time_frame>1 year</time_frame>
      <description>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 &gt;30.5 = normosmia (normal sense of smell)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Self-reported olfactory (smell) function</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gustatory (taste) function</measure>
      <time_frame>1 year</time_frame>
      <description>Taste function will be evaluated by using taste strips (&quot;Taste Strips &quot;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)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Self-reported gustatory (taste) function</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oral pain assessment</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Self-reported oral pain assessment</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional brain connectivity</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measured oral dryness</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical oral dryness</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported oral dryness</measure>
      <time_frame>1 year</time_frame>
      <description>Self-reported oral dryness will be assessed using the Xerostomia Inventory (XI) questionnaire. Scores will range from 11 to 55 points, with values &lt;14 considered as normal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral mucosal status</measure>
      <time_frame>1 year</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral mucositis status</measure>
      <time_frame>1 year</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutritional status</measure>
      <time_frame>1 year</time_frame>
      <description>Nutritional status will be evaluated using the Nutrition Risk Screening 2002 form. Scores range from 0-6. Patients with a score &lt; 3 is considered to be of no nutritional risk. Patients with a score ≥ 3 is considered to be in nutritional risk.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life evaluation</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral health-related quality of life evaluation</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Hematopoietic Stem Cell Transplantation</condition>
    <arm_group>
      <arm_group_label>Patients</arm_group_label>
      <description>Adult recipients of allo-HCST.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls</arm_group_label>
      <description>Healthy adult subjects</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with&#xD;
          either a leukemia or a myelodysplastic syndrome.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed&#xD;
          with either a leukemia or a myelodysplastic syndrome&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  disorders affecting the oral cavity including poor tooth-status&#xD;
  &#xD;
            -  those using drugs affecting the gustatory/olfactory functions&#xD;
  &#xD;
            -  those with brain disorders&#xD;
  &#xD;
            -  those who have a chronic disorder affecting the immune system, have cancer or who are&#xD;
               pregnant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Per Ole Iversen, phd</last_name>
      <role>Study Director</role>
      <affiliation>University of Oslo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Per Ole Iversen, phd</last_name>
      <phone>+47 22 85 13 91</phone>
      <email>p.o.iversen@medisin.uio.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Åsmund Rogn, master</last_name>
      <phone>+47 958 00 328</phone>
      <email>asmund.rogn@odont.uio.no</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Oslo</name>
        <address>
          <city>Oslo</city>
          <zip>0254</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Per Ole Iversen, phd</last_name>
        <phone>+4722851391</phone>
        <email>p.o.iversen@medisin.uio.no</email>
      </contact>
      <contact_backup>
        <last_name>Åsmund Rogn</last_name>
        <phone>+4795800328</phone>
        <email>aasmunro@odont.uio.no</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Oslo</investigator_affiliation>
      <investigator_full_name>Per Ole Iversen, MD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06003660
  org study id: 282886
  nct id: NCT06003660
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Olfactory (smell) function
  time frame: 1 year
  description: 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)
  measure: Self-reported olfactory (smell) function
  time frame: 1 year
  description: 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.
  measure: Gustatory (taste) function
  time frame: 1 year
  description: 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)
  measure: Self-reported gustatory (taste) function
  time frame: 1 year
  description: 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.
  measure: Oral pain assessment
  time frame: 1 year
  description: 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.
  measure: Self-reported oral pain assessment
  time frame: 1 year
  description: 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: Functional brain connectivity
  time frame: 1 year
  description: 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.
  measure: Measured oral dryness
  time frame: 1 year
  description: 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.
  measure: Clinical oral dryness
  time frame: 1 year
  description: 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.
  measure: Self-reported oral dryness
  time frame: 1 year
  description: 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.
  measure: Oral mucosal status
  time frame: 1 year
  description: 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
  measure: Oral mucositis status
  time frame: 1 year
  description: 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)
  measure: Nutritional status
  time frame: 1 year
  description: 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.
  measure: Quality of life evaluation
  time frame: 1 year
  description: 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.
  measure: Oral health-related quality of life evaluation
  time frame: 1 year
  description: 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.
  arm group label: Patients
  description: Adult recipients of allo-HCST.
  arm group label: Controls
  description: Healthy adult subjects
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Per Ole Iversen, phd
  role: Study Director
  affiliation: University of Oslo
  last name: Per Ole Iversen, phd
  phone: +47 22 85 13 91
  email: p.o.iversen@medisin.uio.no
  last name: Åsmund Rogn, master
  phone: +47 958 00 328
  email: asmund.rogn@odont.uio.no
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Norway
  responsible party type: Principal Investigator
  investigator affiliation: University of Oslo
  investigator full name: Per Ole Iversen, MD
  investigator title: Professor