Clinical trial NCT06551857: The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
Official title: The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Hearing Loss Ototoxic
Cognitive Decline
Quality of Life
Keywords: speech perception in noise
ototoxicity
hearing loss
cancer
cisplatin
oxaliplatin
cognition
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients diagnosed with a malignancy that will be treated with curative intent using one of the treatment modalities under investigation (50 patients / group). The study will also include a control group of 50 healthy volunteers.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* 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:

* inability to provide written informed consent
* 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.

Primary outcomes:
measure: Speech perception in noise
timeFrame: 4 months
Secondary outcomes:
measure: Long-term effects on speech perception in noise
timeFrame: 3 years
measure: Short- and long-term effects on high frequency hearing
timeFrame: 3 years
measure: Hearing-related quality of life - Sound quality
timeFrame: 3 years
measure: Hearing-related quality of life - Fatigue
timeFrame: 3 years
measure: Hearing-related quality of life - Tinnitus
timeFrame: 3 years
measure: Treatment-related changes in brain glucose metabolism
timeFrame: 3 years
Other outcomes:
measure: Treatment-related changes in cognition
timeFrame: 3 years
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
Study officials:
affiliation: Turku University Hospital
name: Tytti Willberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: