The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Quality of Life

Phase 1

Active, not recruiting

Conditions: Cancer
MedDRA version: 20.0Level: PTClassification code: 10005003Term: Bladder cancer Class: 100000004864
MedDRA version: 20.0Level: PTClassification code: 10062124Term: Testicular seminoma (pure) Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10067821Term: Head and neck cancer Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code: 10029557Term: Non-seminoma testicular cancer Class: 10029104
MedDRA version: 26.1Level: LLTClassification code: 10018017Term: Gastrointestinal tract cancer NOS Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-513437-21-00

Lead Sponsor: Turku University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

Age 18-75, Diagnosis of a cancer that will be treated with a curative intent with either cisplatin, oxaliplatin, cisplatin-based chemoradiation therapy of the head and neck region or radiation therapy of the head and neck region (subjects in the treatment groups), Age-normative hearing (according to the ISO standard 7029:2017), Ability to provide written informed consent, Native Finnish speaker

Exclusion Criteria

Inability to provide written informed consent, Current or prior major otological condition that has affected or had the potential to affect hearing, Conductive hearing loss or asymmetric hearing loss of any severity, Severe sensorineural hearing loss, Prior malignancy that has been treated with chemotherapeutics and/or radiation therapy, Prior use of ototoxic medication, Any condition that, in the opinion of the investigator, would interfere with adherence to study requirements, Pregnancy, breast-feeding, or aim of becoming pregnant during the study, Allergy or hypersensitivity to study medications or their ingredients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the short-term effect of different cancer treatments on speech perception in noise.;Secondary Objective: To investigate the long-term (1 and 3 years post-treatment) effects of four different type of cancer treatments in speech perception in noise., To investigate the effects of different cancer treatments on high frequency (8-16kHz) hearing., To investigate the effects of different cancer treatments on hearing-related quality of life., To investigate the effects of head and neck cancer treatments on brain in the FDG PET images., To investigate to effect of different cancer treatments on cognition by translating the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) in Finnish and comparing the results to standard neuropsychological assessments.;Primary end point(s): The change in speech perception in noise (measured with the Finnish matrix sentece test) from the baseline to the first follow-up visit at 3-4 months after the end the initial treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Long-term change in the speech perception in noise;Secondary end point(s):Short- and long-term change in extended high frequency hearing;Secondary end point(s):Hearing-related quality of life;Secondary end point(s):Changes in Functional Assessment of Cancer Therapy - Cognitive Function questionnaire and in standardized neuropsychological tests