Cancer, Cognitive Decline, Hearing Loss Ototoxic, Quality of Life
Conditions
Keywords
speech perception in noise, ototoxicity, hearing loss, cancer, cisplatin, oxaliplatin, cognition
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.
Interventions
OTHERChemotherapy, chemoradiation, radiation therapy
Cancer treatment
Sponsors
Turku University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech perception in noise | 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short- and long-term effects on high frequency hearing | 3 years | Treatment-related changes in high frequency (8-16kHz) hearing thresholds |
| Long-term effects on speech perception in noise | 3 years | 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 |
| Hearing-related quality of life - Sound quality | 3 years | 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. |
| Hearing-related quality of life - Fatigue | 3 years | 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. |
| Hearing-related quality of life - Tinnitus | 3 years | 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. |
| Treatment-related changes in brain glucose metabolism | 3 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related changes in cognition | 3 years | 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. |
Countries
Finland
Contacts
Primary ContactTytti Willberg, PhD
Outcome results
None listed