CancerCaSPiNNCT06551857
The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
An observational study of Cancer and Hearing Loss Ototoxic, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Hearing Loss Ototoxic, Cognitive Decline
- What is being tested?
- Chemotherapy, chemoradiation, radiation therapy
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- 2 Oct 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, Southwest Finland, 20521
Tytti Willberg, PhD, +358 2 313 5979, tytti.willberg@varha.fi
About this study
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.
Read the 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.
- Conditions
- Cancer, Hearing Loss Ototoxic, Cognitive Decline, Quality of Life
- Being tested
- Chemotherapy, chemoradiation, radiation therapy
- Keywords
- speech perception in noise, ototoxicity, hearing loss, cancer, cisplatin, oxaliplatin, cognition
- Medical subject headings
- Neoplasms, Cognitive Dysfunction, Ototoxicity, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy, chemoradiation, radiation therapyOther
Cancer treatment
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | 50 patients receiving cisplatin as the standard care for their underlying malignancy Receives: Other: Chemotherapy, chemoradiation, radiation therapy | |
| Cisplatin-based chemoradion therapy in the head and neck region | 50 patients receiving cisplatin-based chemoradiation therapy in the head and neck region as the standard care for their underlying malignancy Receives: Other: Chemotherapy, chemoradiation, radiation therapy | |
| Head and neck region radiation therapy | 50 patient receiving head and neck region radiation therapy as the standard care for their underlying malignancy Receives: Other: Chemotherapy, chemoradiation, radiation therapy | |
| Oxaliplatin | 50 patients receiving oxaliplatin as the standard care for their underlying malignancy Receives: Other: Chemotherapy, chemoradiation, radiation therapy | |
| Control | 50 healthy volunteers who have never received any ototoxic medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (6)
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
Measured: 3 years
Short- and long-term effects on high frequency hearing
Treatment-related changes in high frequency (8-16kHz) hearing thresholds
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start2 Oct 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tytti Willberg, Turku University Hospital
- Investigators
- Tytti Willberg, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551857
- Sponsor's protocol ID
- T1700/2024
- Other IDs
- 2024-513437-21-00
- Acronym
- CaSPiN
- Status last verified
- Apr 2025
- First submitted
- 3 Aug 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
- ClinicalTrials.gov ID
- NCT06551857
- Acronym / sponsor ID
- CaSPiN / T1700/2024
- Conditions
- Cancer, Hearing Loss Ototoxic, Cognitive Decline, Quality of Life
- Keywords
- speech perception in noise, ototoxicity, hearing loss, cancer, cisplatin, oxaliplatin, cognition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | – | Other: Chemotherapy, chemoradiation, radiation therapy50 patients receiving cisplatin as the standard care for their underlying malignancy |
| Cisplatin-based chemoradion therapy in the head and neck region | – | Other: Chemotherapy, chemoradiation, radiation therapy50 patients receiving cisplatin-based chemoradiation therapy in the head and neck region as the standard care for their underlying malignancy |
| Head and neck region radiation therapy | – | Other: Chemotherapy, chemoradiation, radiation therapy50 patient receiving head and neck region radiation therapy as the standard care for their underlying malignancy |
| Oxaliplatin | – | Other: Chemotherapy, chemoradiation, radiation therapy50 patients receiving oxaliplatin as the standard care for their underlying malignancy |
| Control | – | –50 healthy volunteers who have never received any ototoxic medications |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy, chemoradiation, radiation therapyCancer treatment | Other | Cisplatin, Cisplatin-based chemoradion therapy in the head and neck region, Head and neck region radiation therapy, Oxaliplatin |
Primary outcome
Speech perception in noise
Time frame: 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tytti Willberg, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Hearing Loss Ototoxic, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tytti Willberg, PhD (+358 2 313 5979, tytti.willberg@varha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech perception in noise (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.