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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT01693159
Eligibility Criteria:
Inclusion Criteria:
* Locally advanced squamous cell carcinoma of the head and neck and participation in the HICARE-phase-IV-trial
* Cetuximab-induced painful rhagades, i.e. SUPO Score 2-3 (see Figure 2)
* Compliance to the photo documentation
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent
Exclusion Criteria:
* Cetuximab-induced rhagades without any pain, i.e. SUPO Score 1
* Cetuximab-induced rhagades, SUPO Score 4, i.e. superinfection of the rhagades
* Patients not being enrolled in the HICARE trial
* Substance misuse, psychoactive substance abuse or psychological/social conditions leading to a decreased patients' compliance with possible bad influence to the results of the study
* Known allergic reaction to ethyl-2-cyanoacrylate (ECA)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01693159
Study Brief:
Protocol Section:
NCT01693159