Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures. Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO was designed to investigate the impact of tailored physical exercise in patients with vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.
Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures. Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO was designed to investigate the impact of tailored physical exercise in patients with vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design. Patients are randomized to one of the following groups: patients in arm A carry out daily physical training consisting of three different isometric exercises under the guidance and supervision of a physiotherapist. Training starts day one (first radiotherapy session), 10 daily units of 30 min each are scheduled during radiotherapy. Patients are expected to continue training until 12 weeks post completion of radiotherapy at home. Patients in arm B (control group) receive 10 daily sessions of 15 min manual therapy (i.e. massage, etc) starting from day one of radiotherapy. Follow-up of the patients is scheduled at 12 weeks post completion of radiotherapy incl. CT of the spine and physical examination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
tailored isometric physical exercise
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, Germany, Germany
feasibility of isometric exercise in vertebral bony metastases
safety and feasibility of isometric exercise in vertebral bony metastases
Time frame: 12 weeks post completion of radiotherapy
progression-free survival (PFS)
PFS is assessed 2 years post completion of radiotherapy
Time frame: 2 years post completion of radiotherapy
fracture-free survival (FFS)
FFS is assessed 2 years post completion of radiotherapy
Time frame: 2 years post completion of radiotherapy
bone density
bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
Time frame: 12 weeks post completion radiotherapy
pain reduction
pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation therapy
Time frame: end of treatment, 12 and 24 weeks post completion of radiotherapy
Quality of life
Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment
Time frame: 12 and 24 weeks post completion of therapy
Fatigue
Fatigue is assessed using the EORTC FA13 questionnaire
Time frame: 12 and 24 weeks post completion of therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.