The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life (CaSPiN)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Cancer; Cognitive Decline; Hearing Loss Ototoxic
• Intervention / Treatment: Other: Chemotherapy, chemoradiation, radiation therapy

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Tytti Willberg, PhD; Phone Number: +358 2 313 5979; Email: tytti.willberg@varha.fi

Study Locations

• Finland
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20521
      • Recruiting
      • Turku University Hospital
      • Contact: Tytti Willberg, PhD; Phone Number: +358 2 313 5979; Email: tytti.willberg@varha.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cisplatin; 50 patients receiving cisplatin as the standard care for their underlying malignancy	Other: Chemotherapy, chemoradiation, radiation therapy; Cancer treatment
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	Other: Chemotherapy, chemoradiation, radiation therapy; Cancer treatment
Head and neck region radiation therapy; 50 patient receiving head and neck region radiation therapy as the standard care for their underlying malignancy	Other: Chemotherapy, chemoradiation, radiation therapy; Cancer treatment
Oxaliplatin; 50 patients receiving oxaliplatin as the standard care for their underlying malignancy	Other: Chemotherapy, chemoradiation, radiation therapy; Cancer treatment
Control; 50 healthy volunteers who have never received any ototoxic medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years
Short- and long-term effects on high frequency hearing	Treatment-related changes in high frequency (8-16kHz) hearing thresholds	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.	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.	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.	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.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Tytti Willberg, PhD, Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: August 3, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 12, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: cisplatin; oxaliplatin; cancer; cognition; hearing loss; ototoxicity; speech perception in noise
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Cognitive Dysfunction; Hearing Loss; Deafness
• Other Study ID Numbers: T1700/2024; 2024-513437-21-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No