Clinical trial · Observational
Effect of stRess and exeRcize on the Outcome After Chemo-Radiation
NCT05431348CI-TRIAL-00104553ERRORcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Glioblastoma (GBM) is a highly malignant, incurable primary brain tumor. Due to the nature of this disease and the extent of the treatment (surgery followed by chemoradiation according to the Stupp trial) patients undergo considerable psychological distress. It is known that stress hormones are involved in a wide range of processes involved in cell survival, cell cycle and immune function, and can cause therapy resistance. In this study the effect of stress on outcome after chemoradiation in patients with GBM will be investigated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Other | — | UNRESOLVED |
| Serum Cortisol | Diagnostic Test | — | UNRESOLVED |
| Smartwatch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- patients with glioblastoma treated with STUPP schema
- interventionNames
- Device: Smartwatch
- Diagnostic Test: Serum Cortisol
- Other: Questionnaires
Primary outcomes (2)
- measure
- Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)?
- timeFrame
- 1 year
- description
- Stress variables are heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to overall survival at 1 year (survival = yes/no)
- measure
- Is stress a prognostic factor for the progression free- survival at 1 year of patients with glioblastoma (GBM)?
- timeFrame
- 1 year
- description
- Stress variables are heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to progression free survival at 1 year (progression free survival at 1 year; yes/no)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients treated with Stupp or Elderly protocol: GBM WHO IV, astrocytoma WHO IV IDHmt, astrocytoma WHO II IDHwt (GBM-like). * willing to wear the smart watch during the treatment protocol Exclusion Criteria: * younger than 18 years * not in possession of a smart phone
References
Publications (5)
- BACKGROUNDStupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9. PMID 19269895
- BACKGROUNDZabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6. PMID 11180574
- BACKGROUNDSehlen S, Hollenhorst H, Schymura B, Herschbach P, Aydemir U, Firsching M, Duhmke E. Psychosocial stress in cancer patients during and after radiotherapy. Strahlenther Onkol. 2003 Mar;179(3):175-80. doi: 10.1007/s00066-003-1018-z. PMID 12627260
- BACKGROUNDKelly C, Majewska P, Ioannidis S, Raza MH, Williams M. Estimating progression-free survival in patients with glioblastoma using routinely collected data. J Neurooncol. 2017 Dec;135(3):621-627. doi: 10.1007/s11060-017-2619-1. Epub 2017 Sep 27. PMID 28956223
- BACKGROUNDMattern J, Buchler MW, Herr I. Cell cycle arrest by glucocorticoids may protect normal tissue and solid tumors from cancer therapy. Cancer Biol Ther. 2007 Sep;6(9):1345-54. doi: 10.4161/cbt.6.9.4765. Epub 2007 Jul 19. PMID 18087223