The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorTurku University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Chemotherapy, chemoradiation, radiation therapy
Other interventionCancer treatment
Treatment groups
250 Participants
are divided into 5 treatment groupsGroup A: Cisplatin1 intervention
Group B: Cisplatin-based chemoradion therapy in the head and neck region1 intervention
Group C: Head and neck region radiation therapy1 intervention
Group D: Oxaliplatin1 intervention
Group E: Control0 interventions
Trial outcomes
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.
Time frame
4 monthsSecondary outcomes
1
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
Time frame
3 years2
Short- and long-term effects on high frequency hearing
Treatment-related changes in high frequency (8-16kHz) hearing thresholds
Time frame
3 years3
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.
Time frame
3 years4
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.
Time frame
3 yearsOther outcomes
1
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.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov