Prognostic Potential of Olfactory Function in Glioblastoma: a Prospective Observational Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSied Kebir
About this trial
The study aims to investigate the prognostic significance of olfactory function in patients with glioblastoma. We are examining olfactory function at various points during therapy and correlating the results with survival data. In addition, neurocognitive tests will be carried out to correlate the results of olfactory function with the patient's cognitive abilities. Investigations into the quality of life and psychological condition of the patients are also performed. In addition to the cohort of glioblastoma patients, there is a control cohort without tumor disease in which the olfactory testing is also carried out in order to have a comparison.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 18 years of age
Newly-diagnosed glioblastoma (IDH wild-type)
Never received prior chemotherapy
Never received radiotherapy to the head or neck before
Disqualifiers
Presence of Neurodegenerative diseases (e.g. Parkinson's disease, Alzheimer's disease, Huntington's disease, Korsakoff's syndrome, Pick's disease, Shy-Drager syndrome)
History of invasive tumors or surgery in the head or neck area, except for surgeries for non-invasive skin tumors (e.g. basal cell carcinomas)
Permanent olfactory impairment following infections (e.g., influenza, coronavirus)
Conditions that, in the examiner's judgment, could interfere with the participant's study compliance (e.g., schizophrenia)
Trial population
Newly-diagnosed glioblastoma
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
olfactory testing (threshold and identification test)
Diagnostic testIn the identification test, 12 sniffin sticks are presented, which the patient has to name using a selection card with four terms each. Both nostrils are tested individually at each visit during the identification test. A correct answer scores one point. A maximum of 12 points is possible. The threshold test consists of 16 dilution levels. Each level contains one sniffin stick with odor and two blanks. All three sniffin sticks of a dilution level are presented to the patient one after the other with eyes closed. The patient must indicate which of the three sticks contains an odor. Depending on whether the patient gives the correct answer, the three sniffin sticks in the next higher or next lower level are presented next. A maximum of 16 points is possible.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Newly-diagnosed glioblastoma cohort1 intervention
Group B: Control cohort1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
Overall survival in relation to olfactory function
Time frame
From tumor diagnosis to death (usually 6 to 24 months)Secondary outcomes
1
Progression free survival
Progression free survival in relation to olfactory function
Time frame
From date of first surgery until the date of first progression (MRI)2
Neurocognition
Neurocognition in relation to olfactory function The following tests are used for neurocognition testing: * Immediate and delayed story recall from the Rivermead Behavioural Memory Test * Number span (forward and backward) and block span (forward and backward) from the Wechsler Memory Scale * Phonemic word fluency from the Regensburg Word Fluency Test (phonemic) * Trail Making Test A and B
Time frame
From enrollment to 2 years after the end of radiotherapy3
Quality of Life (QoL)
Quality of Life in relation to olfactory function The following questionnaires are used to assess quality of life: * EORTC QLQ-C30 (Version 3.0; Part A with 28 questions on a Likert scale, 28 to 112 points, Higher score means lower quality of life; Part B with 2 questions on a Likert scale, 2 to 14 points, Lower score means lower quality of life ) * EORTC QLQ-BN20 (20 questions on a Likert scale; 20 to 80 points; Higher score means lower quality of life)
Time frame
From enrollment to 2 years after the end of radiotherapy4
Psychological condition
Psychological well-being in relation to olfactory function The following psychiatric questionnaires are used: * Patient Health Questionnaire-8 (PHQ-8): 8 questions on a Likert scale, score 0 to 24, higher score indicate more depression * Generalized Anxiety Disorder 7 (GAD-7): 7 questions on a Likert scale, score 0 to 21, higher score indicate more anxiety * National Comprehensive Cancer Network (NCCN) Distress Thermometer: Score 1 to 10, higher score indicate more distress
Time frame
From enrollment to 2 years after the end of radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sied Kebir
Lead sponsor
University Hospital, Essen
Sponsor institution
Münster University Hospital, Germany
Collaborator
Source ClinicalTrials.gov