Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02129335 : Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02129335      |      Link to official Clinicaltrials.gov listing
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