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

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ClinicalTrials.gov Identifier: NCT02129335
Recruitment Status : Terminated (insufficient enrollment)
First Posted : May 2, 2014
Last Update Posted : May 17, 2017
Sponsor:
Collaborators:
University Hospital, Zürich
Luzerner Kantonsspital
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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. Is there a prognostic significance of stress in patients with newly diagnosed GBM on treatment tolerance and (progression free) survival?
  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. How is the longitudinal course of patients and partners stress and physical condition over the disease course and do they influence (progression free) survival?

Answers to these questions will help to establish future projects studying non drug interventions in patients and patients partners to help improving clinical and tumor related outcome in patients with newly diagnosed GBM.

The investigators hypothesize that chronic stress, specifically measured as a disruption of the diurnal cortisol rhythmicity, is an independent prognostic factor in patients with GBM. Furthermore, physical activity of patients and stress level in patients` partners may impact - as stress-modulating factors- on stress in patients and on their prognosis.

Aiming at identifying stress-related prognostic factors as potential targets for novel treatment approaches, we propose, in a first step, a prospective multicenter cohort study: all patients with newly diagnosed GBM and good performance status (KPS ≥ 50%) who undergo standard treatment with combined radiochemotherapy with temozolomide (RCT) followed by 6 month of cyclic temozolomide, are eligible. In addition, one "partner", defined as a close person living in the same home or close daily contact to the patient, will be asked for inclusion.


Condition or disease Intervention/treatment
Neoplasms Glioblastoma Other: stress

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner (TOGETHER-study): a Prospective Multicenter Cohort Study.
Study Start Date : April 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
stress
patient with glioblastoma diagnosis and partners
Other: stress
stress level and survival




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 month ]
    analysis


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 month ]
    analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed GBM with one Partner.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129335


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Kantonsspital Luzern
Luzern, Switzerland, 6000
University Hospital Neurology
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Hospital, Zürich
Luzerner Kantonsspital
University Hospital Inselspital, Berne
Investigators
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Study Chair: Viviane Hess, MD University Hospital, Basel, Switzerland
Principal Investigator: Katrin Conen, MD University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02129335     History of Changes
Other Study ID Numbers: TOGETHER
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Basel, Switzerland:
glioblastoma
partner
stress
exercise
outcome

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue