Effect of stRess and exeRcize on the Outcome After Chemo-Radiation

NCT05431348 | Completed

• 1 other identifier: ERROR
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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

Glioblastoma (GBM)

Keywords

stress; glioblastoma; survival; quality of life

Outcome Measures

Primary Outcomes (2)

• Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)?

  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)

  1 year

• Is stress a prognostic factor for the progression free- survival at 1 year of patients with glioblastoma (GBM)?

  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)

  1 year

Secondary Outcomes (4)

• Is stress a prognostic factor for the quality of life of patients with GBM

  1 year

• Is stress a prognostic factor for dose limiting toxicities (CTC) of the treatment?

  1 year

• Is stress a prognostic factor for early termination of the treatment?

  1 year

• Is there a relationship between stress and treatment response measures on MRI imaging

  6 months

Study Arms (1)

patients with glioblastoma treated with STUPP schema

Device: Smartwatch; Diagnostic Test: Serum Cortisol; Other: Questionnaires

Interventions

Serum Cortisol DIAGNOSTIC_TEST

Level of cortisol in serum will be determined

patients with glioblastoma treated with STUPP schema

Questionnaires OTHER

Patients are asked to fill in patient reported outcomes (PROMS) and specific questions on stress, exercise and fatigue (QSC-R23, IPAQ-SF, MVI-20)

patients with glioblastoma treated with STUPP schema

Smartwatch DEVICE

Patients will wear the smartwatch during treatment which measures, activity, steps, sleep and heartrate

patients with glioblastoma treated with STUPP schema

Eligibility Criteria

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

Study Population

Patients with a glioblastoma (GBM) eligible for treatment with STUPP or Elderly treatment protocol (concurrent radio-chemotherapy + temozolomide)

You may qualify if:

• 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

You may not qualify if:

• younger than 18 years
• not in possession of a smart phone

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator
• Zuyderland Medical Centre: collaborator
• Verbeeten Institute Tilburg: collaborator

Study Sites (2)

Maastricht Radiation Oncology (Maastro)

Maastricht, Limburg, 6229ET, Netherlands

Location

Verbeeten Insitute Tilburg

Tilburg, Netherlands

Location

Related Publications (5)

• Stupp 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 BACKGROUND

• Zabora 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 BACKGROUND

• Sehlen 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 BACKGROUND

• Kelly 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 BACKGROUND

• Mattern 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 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Karen Zegers, PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: June 24, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)