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

NCT02129335 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2017-05-17

No results posted yet for this study

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.

Conditions

Interventions

OTHER

stress

stress level and survival

Sponsors & Collaborators

  • University Hospital, Zürich

    collaborator OTHER
  • Luzerner Kantonsspital

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER
  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Viviane Hess, MD · University Hospital, Basel, Switzerland

  • Katrin Conen, MD · University Hospital, Basel, Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-10-31
Completion
2017-05-31

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02129335 on ClinicalTrials.gov