Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner

NCT02129335 | Terminated DMC

• 1 other identifier: TOGETHER
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

Glioblastoma multiforme (GBM) is the most common malignant central nervous system (CNS) tumor in adulthood with a median survival of 12-16 months. The drastically shorted life expectancy, intellectual changes and rapid physical decline in those patients are devastating and do impose a profound chronic stress on patients and their families. There is extensive evidence that chronic stress can promote cancer growth and progression. In the setting of GBM patients, three major questions still have to be answered and will be analysed in this study:

1. 1.Is there a prognostic significance of stress in patients with newly diagnosed GBM on treatment tolerance and (progression free) survival?
2. 2.Can this stress be modulated by other factors, like stress of patients partners and patients physical activity, a known independent prognostic factor in recurrent glioma patients?
3. 3.How is the longitudinal course of patients and partners stress and physical condition over the disease course and do they influence (progression free) survival?

Conditions

Neoplasms; Glioblastoma

Keywords

glioblastoma; partner; stress; exercise; outcome

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  analysis

  12 month

Secondary Outcomes (1)

• Overall survival

  12 month

Study Arms (1)

stress

patient with glioblastoma diagnosis and partners

Other: stress

Interventions

stress OTHER

stress level and survival

stress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed GBM with one Partner.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University Hospital, Zürich: collaborator
• Luzerner Kantonsspital: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (3)

University Hospital Basel

Basel, 4031, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

University Hospital Neurology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Neoplasms; Glioblastoma; Motor Activity

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Behavior

Study Officials

• Viviane Hess, MD

  University Hospital, Basel, Switzerland

  STUDY CHAIR

• Katrin Conen, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: May 2, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

CH (3)