CISPLATIN for Cancer | Head and neck cancer | Bladder cancer | Testicular cancer (seminoma and non-seminoma) | Gastrointestinal tract cancer

Inclusion criteria

• {"criterion_text":"- Age 18-75"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Age-normative hearing (according to the ISO standard 7029:2017)"}
• {"criterion_text":"- Ability to provide written informed consent"}
• {"criterion_text":"- Native Finnish speaker"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured with the Finnish matrix sentence test comparing baseline to the first follow-up visit at 3-4 months after the end of the initial treatment."}

Secondary endpoints

• {"endpoint_text":"- Long-term change in the speech perception in noise","definition_or_measurement_approach":"Long-term changes in speech perception in noise measured over follow-up (secondary objectives reference assessments at 1 and 3 years post-treatment)."}
• {"endpoint_text":"- Short- and long-term change in extended high frequency hearing","definition_or_measurement_approach":"Changes in extended high frequency hearing measured at short- and long-term follow-up visits (specific audiometric methods not detailed here)."}
• {"endpoint_text":"- Hearing-related quality of life","definition_or_measurement_approach":"Assessment of hearing-related quality of life using questionnaires (specific instrument not detailed in the provided record)."}
• {"endpoint_text":"- Changes in Functional Assessment of Cancer Therapy - Cognitive Function questionnaire and in standardized neuropsychological tests","definition_or_measurement_approach":"FACT-Cog questionnaire (translated to Finnish) and standardized neuropsychological tests to assess cognitive changes."}

Finland

Earliest CTIS Part Ii Submission Date

19-06-2024

Latest Decision Or Authorization Date

26-07-2024

Processing Time Days

37

Number Of Sites

1

Number Of Participants

250

Primary sponsor

Full Name

Turku University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland

Third parties

• {"country":"","full_name":"Other non-profit foundations supporting scientific research","duties_or_roles":"Monetary support / funding","organisation_type":""}
• {"country":"","full_name":"Turku University Hospital Foundation","duties_or_roles":"Monetary support / funding","organisation_type":""}
• {"country":"","full_name":"The Wellbeing Services County of South West Finland State research funding","duties_or_roles":"Monetary support / funding","organisation_type":""}
• {"country":"","full_name":"Finnish Audiological Society Research Funding","duties_or_roles":"Monetary support / funding","organisation_type":""}
• {"country":"","full_name":"The Finnish ORL-HNS Foundation (Korvatautien tutkimussäätiö)","duties_or_roles":"Monetary support / funding","organisation_type":""}