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AzTrials

Glioblastoma (GBM)ERRORNCT05431348

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

An observational study of Glioblastoma (GBM), run by Maastricht Radiation Oncology at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma (GBM)
What is being tested?
Smartwatch, Serum Cortisol and Questionnaires
Type of treatment
Medical device
How many people
42 participants
Where
2 sitesNetherlands
Study dates
1 Jun 2022to 1 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Maastricht Radiation Oncology (Maastro)

    Maastricht, Limburg, 6229ET

  • Verbeeten Insitute Tilburg

    Tilburg

Other trials in Netherlands

About this study

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.

Read the detailed description

Psychological stress will be measured using multiple approaches; Physiological measures, stress biomarker and questionnaires. Using this approach, a broad insight in the relationship between stress and outcome after chemoradiation will be obtained and the potential influence of physical activity and sleep evaluated. In addition, the results of this study will help to identify patients which experience high stress levels during chemoradiation to pilot (in the future) interventions to reduce stress before and during treatment.

Being tested
Smartwatch, Serum Cortisol, Questionnaires
Keywords
stress, glioblastoma, survival, quality of life
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmartwatchDevice

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

  • Serum CortisolDiagnostic test

    Level of cortisol in serum will be determined

  • QuestionnairesOther

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

Study groups in NCT05431348
Study groupRoleWhat they receive
patients with glioblastoma treated with STUPP schemaNot described
Receives: Device: Smartwatch; Diagnostic Test: Serum Cortisol; Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 year

  2. 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)

    Measured: 1 year

Secondary outcomes (4)

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

    Stress variables like heartrate, sleep, serum cortisol and the Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to quality of life (EuroQol 5D)

    EuroQol 5D: The 5 questions on the health condition will be scored on a 3-point scale (1-3) By placing these numbers after each other a 5-digit index will occur which provides the health profile. This 5-digit number can be re-calculated to a total score.

    Measured: 1 year

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

    Stress variables like heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to EORTC Common Toxicity Criteria (CTC) score.

    CTC: ranging from grade 1: mild to 5: death

    Measured: 1 year

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

    Stress variables like heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to early treatment cessation.

    early treatment cessation (yes/no)

    Measured: 1 year

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

    Stress variables like heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to potential changes in clinical MRI (clinical significant edema and/or clinical significant radionecrosis)

    Potential changes in clinical MRI (yes/no)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start1 Jun 2022
  3. Primary completion1 Mar 2026
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431348
Sponsor's protocol ID
ERROR
Acronym
ERROR
Status last verified
Mar 2026
First submitted
22 Feb 2022
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19269895

  • 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.

    PubMed 11180574

  • 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.

    PubMed 12627260

  • 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.

    PubMed 28956223

  • 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.

    PubMed 18087223

Questions about this trial

What is this clinical trial studying?

An observational study of Glioblastoma (GBM), run by Maastricht Radiation Oncology at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)? (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431348, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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