Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT06551857
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06551857
Study Brief:
Protocol Section:
NCT06551857