The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life

Last updated: April 12, 2025
Sponsor: Turku University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Memory Loss

Dementia

Treatment

Chemotherapy, chemoradiation, radiation therapy

Clinical Study ID

NCT06551857
T1700/2024
2024-513437-21-00
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study will assess the effect of cancer treatments on speech perception in noise, cognition, and hearing-related quality of life by monitoring 200 cancer patients receiving standard care for their underlying malignancy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • written informed consent

  • native Finnish speaker

  • age-normative hearing

  • for participants in the treatment arms: diagnosis of a malignancy that will betreated with curative intent with any of the following: 1) Cisplatin as the mainchemotherapeutic agent, 2) oxaliplatin as the main chemotherapeutic agent, 3)cisplatin-based chemoradiation therapy in the head and neck region, 4) radiationtherapy in the head and neck region

Exclusion

Exclusion Criteria:

  • inability to provide written informed consent

  • Current or prior major otological condition that has affected or has had thepotential 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, mayeither put the subject at risk by participation in the trial, or may influence theresult of the trial.

  • Any condition that, in the opinion of the investigator, would interfere withadherence 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.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Chemotherapy, chemoradiation, radiation therapy
Phase:
Study Start date:
October 02, 2024
Estimated Completion Date:
December 31, 2030

Study Description

The study will assess the effects of four different types of cancer treatments on speech perception in noise, hearing thresholds, cognition, and hearing-related quality of life over a follow-up period of 3 years.

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.

Connect with a study center

  • Turku University Hospital

    Turku, Varsinais-Suomi 20521
    Finland

    Active - Recruiting

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