Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

BrainFlavor: Brain Neuronal Networks and Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003660
• Other study ID #: 282886
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: University of Oslo
• Contact: Per Ole Iversen, phd
• Phone: +47 22 85 13 91
• Email: p.o.iversen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	1 year
Primary	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
Secondary	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
Secondary	Clinical oral dryness	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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