The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
CaSPiN
2 other identifiers
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2024
CompletedFirst Posted
Study publicly available on registry
August 13, 2024
CompletedStudy Start
First participant enrolled
October 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 16, 2025
April 1, 2025
5.2 years
August 3, 2024
April 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 months
Secondary Outcomes (6)
Long-term effects on speech perception in noise
3 years
Short- and long-term effects on high frequency hearing
3 years
Hearing-related quality of life - Sound quality
3 years
Hearing-related quality of life - Fatigue
3 years
Hearing-related quality of life - Tinnitus
3 years
- +1 more secondary outcomes
Other Outcomes (1)
Treatment-related changes in cognition
3 years
Study Arms (5)
Cisplatin
50 patients receiving cisplatin as the standard care for their underlying malignancy
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
Head and neck region radiation therapy
50 patient receiving head and neck region radiation therapy as the standard care for their underlying malignancy
Oxaliplatin
50 patients receiving oxaliplatin as the standard care for their underlying malignancy
Control
50 healthy volunteers who have never received any ototoxic medications
Interventions
Cancer treatment
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku University Hospital
Turku, Southwest Finland, 20521, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tytti Willberg, PhD
Turku University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 3, 2024
First Posted
August 13, 2024
Study Start
October 2, 2024
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2030
Last Updated
April 16, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
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.