RecruitingNCT06954636

Prognostic Potential of Olfactory Function in Glioblastoma: a Prospective Observational Study


Sponsor

Sied Kebir

Enrollment

128 participants

Start Date

May 3, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria8

  • 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
  • KPS ≥ 70
  • No history of severe head or brain trauma requiring ICU admission or classified as Glasgow Coma Scale grade 3
  • No respiratory infection at the time of inclusion
  • No significant aphasia

Exclusion Criteria5

  • 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)
  • Language barriers likely to interfere with participation or comprehension of study procedures.

Interventions

DIAGNOSTIC_TESTolfactory testing (threshold and identification test)

In 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.


Locations(2)

University Hospital Essen, Department of Neurology, Division of Clinical Neuro-Oncology

Essen, Germany

Department of Neurosurgery

Münster, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06954636


Related Trials