Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, Germany, 69120
NCT Number: NCT01409720
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Heidelberg, Germany, 69120
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tailored isometric physical exercise
Time frame: 12 weeks post completion of radiotherapy
safety and feasibility of isometric exercise in vertebral bony metastases
Time frame: 2 years post completion of radiotherapy
PFS is assessed 2 years post completion of radiotherapy
Time frame: 2 years post completion of radiotherapy
FFS is assessed 2 years post completion of radiotherapy
Time frame: 12 weeks post completion radiotherapy
bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
Time frame: 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
Time frame: 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
Time frame: 12 and 24 weeks post completion of therapy
Fatigue is assessed using the EORTC FA13 questionnaire
Heidelberg University
Other
Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy
Acronym: DISPO
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