The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
NCT ID: NCT06551857
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2024-10-02
2030-12-31
Brief Summary
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Detailed Description
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The speech perception in noise will be assessed using the Finnish matrix sentence test. Other hearing measures include transient and distortion product otoacoustic emissions, impedance audiometry and pure-tone audiometry extending to high frequencies (0.125kHz - 16kHz).
Hearing-related quality of life will be assessed using Speech, Spatial, and Qualities 12 -questionnaire, Vanderbilt Fatigue Scale 10 -questionnaire and Tinnitus Handicap Index. Cognitive functions will be assed using Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire and neuropsychological tests. The neuropsychological tests included in the study are Continuous Performance Test, Continuous Auditory Test of Attention, Trail Making Test A \& B, Stroop Test, Coding and Digit span tasks from the Wechsler Adult Intelligence Scale - Fourth Edition, Word List task from Wechsler Memory Scale III, and Controlled Oral Word Association Test.
Neuropsychological assessments will be conducted at baseline and 1 year and 3 years after the end of the treatments. All other assessments will be conducted at baseline and at 3-4 months, 1 year, and 3 years after the end of the initial treatments.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cisplatin
50 patients receiving cisplatin as the standard care for their underlying malignancy
Chemotherapy, chemoradiation, radiation therapy
Cancer treatment
Cisplatin-based chemoradion therapy in the head and neck region
50 patients receiving cisplatin-based chemoradiation therapy in the head and neck region as the standard care for their underlying malignancy
Chemotherapy, chemoradiation, radiation therapy
Cancer treatment
Head and neck region radiation therapy
50 patient receiving head and neck region radiation therapy as the standard care for their underlying malignancy
Chemotherapy, chemoradiation, radiation therapy
Cancer treatment
Oxaliplatin
50 patients receiving oxaliplatin as the standard care for their underlying malignancy
Chemotherapy, chemoradiation, radiation therapy
Cancer treatment
Control
50 healthy volunteers who have never received any ototoxic medications
No interventions assigned to this group
Interventions
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Chemotherapy, chemoradiation, radiation therapy
Cancer treatment
Eligibility Criteria
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Inclusion Criteria
* native Finnish speaker
* age-normative hearing
* for participants in the treatment arms: diagnosis of a malignancy that will be treated with curative intent with any of the following: 1) Cisplatin as the main chemotherapeutic agent, 2) oxaliplatin as the main chemotherapeutic agent, 3) cisplatin-based chemoradiation therapy in the head and neck region, 4) radiation therapy in the head and neck region
Exclusion Criteria
* Current or prior major otological condition that has affected or has had the potential to affect hearing
* Conductive or asymmetric sensorineural HL of any severity
* Severe sensorineural HL
* Prior malignancy treated with chemotherapeutics or radiation therapy
* Prior use of ototoxic medications
* Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the trial, or may influence the result of the trial.
* Any condition that, in the opinion of the investigator, would interfere with adherence to the trial requirements.
For participants in the treatment arms:
* Allergy or hypersensitivity to trial medications or their ingredients
* Pregnancy or breast-feeding, aim of becoming pregnant during the trial.
18 Years
75 Years
ALL
Yes
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Tytti Willberg
Principal Investigator
Principal Investigators
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Tytti Willberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Locations
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Turku University Hospital
Turku, Southwest Finland, Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-513437-21-00
Identifier Type: CTIS
Identifier Source: secondary_id
T1700/2024
Identifier Type: -
Identifier Source: org_study_id
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