An observational study in Cancer, Hearing Loss Ototoxic and Cognitive Decline, sponsored by Turku University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Turku University Hospital · Observational
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 250 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For participants in the treatment arms:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 patients receiving cisplatin as the standard care for their underlying malignancy
Other: Chemotherapy, chemoradiation, radiation therapy
50 patients receiving cisplatin-based chemoradiation therapy in the head and neck region as the standard care for their underlying malignancy
Other: Chemotherapy, chemoradiation, radiation therapy
50 patient receiving head and neck region radiation therapy as the standard care for their underlying malignancy
Other: Chemotherapy, chemoradiation, radiation therapy
50 patients receiving oxaliplatin as the standard care for their underlying malignancy
Other: Chemotherapy, chemoradiation, radiation therapy
50 healthy volunteers who have never received any ototoxic medications
Cancer treatment
Speech perception in noise
The treatment-related change in speech perception in noise (in decibel signal-to-noise ratio (db SNR)) from baseline to first follow-up at 3-4 months after the end of the treatment.
Time frame: 4 months
Long-term effects on speech perception in noise
Treatment-related long-term changes in speech perception in noise (in decibel signal-to-noise ratio (dB SNR)) measured with the Finnish matrix sentence test
Time frame: 3 years
Short- and long-term effects on high frequency hearing
Treatment-related changes in high frequency (8-16kHz) hearing thresholds
Time frame: 3 years
Hearing-related quality of life - Sound quality
Treatment-related changes in hearing related quality of life measured using the total score from Speech, Spatial, and Qualities 12 question questionnaire (SSQ-12). Responses are given with a VAS scale from 0 to 10, with 10 indicating perfect hearing performance and 0 worst possible performance. Range for total scores is 0-120, and decrease in scores indicates deterioration in hearing-related quality of life.
Time frame: 3 years
Hearing-related quality of life - Fatigue
Treatment-related changes in hearing-related fatigue are measured using the total score from Vanderbilt Fatigue Scale for Adults (10 question version, VFS-A-10). Responses are given in a 5-point Likert scale. The range for total scores is 0-40 with higher scores indicating more fatigue / worse score. An increase in the total score indicates increased listening-related fatigue.
Time frame: 3 years
Hearing-related quality of life - Tinnitus
Treatment-related changes in tinnitus symptoms are measured using the total score from Tinnitus Handicap Inventory (THI). The questionnaire provides a total score between 0 and 100, with larger score indicating more tinnitus-related handicap. An increase in the total score indicates increased tinnitus-related handicap.
Time frame: 3 years
Treatment-related changes in brain glucose metabolism
Treatment-related brain changes are evaluated from the FDG PET by assessing the voxel-wise mean change in the standardized uptake value ratios (SUVRs) from baseline to follow-up. Decrease in SUVRs indicates treatment-related decrease in brain glucose metabolism.
Time frame: 3 years
Treatment-related changes in cognition
Treatment-related changes in cognition are evaluated using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire. Responses are given in a five-point Likert-type scale and are presented as subscale scores for four domains: perceived cognitive impairments, impact of perceived cognitive impairments on quality of life, comments from others, and perceived cognitive abilities. Higher score indicates better perceived performance.
Time frame: 3 years
Plan to share: No — The data is collected from a clearly specified patient population and includes personal information that can be used to identify individual participants, even after pseudonymization. Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and Analytic Code will be shared through Open Science Framework immediately following publication and be available with no end date.
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