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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT02129335
Eligibility Criteria:
Inclusion Criteria:
Patients:
* age ≥18 years
* Karnofsky Performance Score ≥ 50 %
* histologically confirmed, previously untreated GBM
* radiochemotherapy according to Stupp et al \[1\] is planned (ideally, treatment start can be scheduled on a Monday)
* no cardiovascular or neurological contraindications for 6MWT and/or a history of instable angina pectoris or NYHA grade II or greater congestive heart failure (according to the Thoracic Society recommendations \[2\])
* willing and able to comply with the protocol as judged by the investigator
* signed informed consent
Partners:
* age ≥18 years
* willing and able to comply with the protocol as judged by the investigator
* spouse or partner living in the same home as the patient or closest contact as named by the patient (1-2h 5 days a week)
* signed informed consent
Exclusion Criteria:
Patients:
* Patients who have any other disease, either metabolic or psychological, or who have any evidence on clinical examination or special investigations (including laboratory findings) which give reasonable suspicion of a condition that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids ≥ 3 months before study entry for disease other than glioblastoma, (dexamethasone use in the context of glioblastoma is allowed)
* Severe, medically treated psychiatric disorder prior to the diagnosis of glioblastoma
* Participation in a study with investigational drugs
* Severe asthma or known allergy against tetracosactide (Synacthen®)
* Pregnancy or breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurologic deficits that interfere with the planned walking tests, dementia or confusional state
Partners:
* Individuals who have any disease, either metabolic or psychological, that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids (≥ 3 months), psychiatric disorders)
* Pregnancy or breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02129335
Study Brief:
Protocol Section:
NCT02129335