The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemotherapy, chemoradiation, radiation therapy.
- Who it may be relevant to
- Registry conditions: Cancer, Hearing Loss Ototoxic, Cognitive Decline, Quality of Life. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Chemotherapy, chemoradiation, radiation therapy
Cancer treatment
Primary outcome measures
- Speech perception in noise [Time frame: 4 months]
Secondary outcome measures (6)
- Long-term effects on speech perception in noise [Time frame: 3 years]
- Short- and long-term effects on high frequency hearing [Time frame: 3 years]
- Hearing-related quality of life - Sound quality [Time frame: 3 years]
- Hearing-related quality of life - Fatigue [Time frame: 3 years]
- Hearing-related quality of life - Tinnitus [Time frame: 3 years]
- Treatment-related changes in brain glucose metabolism [Time frame: 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Finland · 1 center
- Turku University Hospital — Turku
Identifiers
NCT: NCT06551857 · T1700/2024 · 2024-513437-21-00