Vertebral Bony Metastases
Conditions
Keywords
bony metastases, physical exercise
Brief summary
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.
Detailed description
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.
Interventions
OTHERexercise
tailored isometric physical exercise
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* solitary or multiple vertebral metastases * thoracic spine * lumbar spine * sacrum * indication for palliative radiation therapy * age: 18 - 80 years * Karnofsky index \> 70% * bisphosphonate therapy inititated
Exclusion criteria
* bony metastases of cervical spine or pelvis * impending fracture * other serious illnesses or medical conditions: therapy-refractory unstable heart disease, congestive heart failure NYHA °III and °IV; coagulopathies * Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators * Legal incapacity or limited legal capacity * Positive serum/ urine beta-HCG/ pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of isometric exercise in vertebral bony metastases | 12 weeks post completion of radiotherapy | safety and feasibility of isometric exercise in vertebral bony metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fracture-free survival (FFS) | 2 years post completion of radiotherapy | FFS is assessed 2 years post completion of radiotherapy |
| bone density | 12 weeks post completion radiotherapy | bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine |
| progression-free survival (PFS) | 2 years post completion of radiotherapy | PFS is assessed 2 years post completion of radiotherapy |
| Quality of life | 12 and 24 weeks post completion of therapy | Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment |
| Fatigue | 12 and 24 weeks post completion of therapy | Fatigue is assessed using the EORTC FA13 questionnaire |
| pain reduction | end of treatment, 12 and 24 weeks post completion of radiotherapy | pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation therapy |
Countries
Germany
Outcome results
None listed