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

Glioblastoma (GBM) Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431348
• Other study ID #: ERROR
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Maastricht Radiation Oncology
• Contact: Karen Zegers, PhD
• Phone: 0884455666
• Email: karen.zegers[@]maastro.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with GBM eligible for Stupp treatment

• willing to wear the smart watch during the treatment protocol

Exclusion Criteria:

• younger than 18 years

• not in possession of a smart phone

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma (GBM)

Intervention

Device:
• Smartwatch
Patients will wear the smartwatch during treatment which measures, activity, steps, sleep and heartrate

Diagnostic Test:
• Serum Cortisol
Level of cortisol in serum will be determined

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

Locations

Country	Name	City	State
Netherlands	Maastricht Radiation Oncology (Maastro)	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View Citation

Mattern J, Büchler 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. Epub 2007 Jul 19. Review. — View Citation

Sehlen S, Hollenhorst H, Schymura B, Herschbach P, Aydemir U, Firsching M, Dühmke E. Psychosocial stress in cancer patients during and after radiotherapy. Strahlenther Onkol. 2003 Mar;179(3):175-80. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	1 year
Secondary	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	1 year
Secondary	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)	1 year
Secondary	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)	6 months