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NCT Number: NCT05431348

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

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.

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Key information

Conditions

Glioblastoma (GBM) Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht Radiation Oncology (Maastro), Maastricht, Limburg, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartwatch

Device

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

Serum Cortisol

Diagnostic Test

Level of cortisol in serum will be determined

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)

Primary outcomes

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

    Time frame: 1 year

    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)

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

    Time frame: 1 year

    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)

Secondary outcomes

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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

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

    Time frame: 1 year

    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)

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

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Maastricht University Medical Center
  • Verbeeten Institute Tilburg
  • Zuyderland Medical Centre

Registry information

Acronym: ERROR

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2022
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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