NCT05431348

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Maastricht Radiation Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Glioblastoma (GBM)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-06-24
• Last updated: 2026-03-04

Locations

2 sites across 1 country: Netherlands