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A 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. exercise tailored isometric physical exercise

Patients in arm B (control group) receive 10 daily sessions of 15 min progressive muscle relaxation starting from day one of radiotherapy.

Exercises in the "all-fours" position Exercises in the "swimming" Position Exercises in the "forearm support" Position Exercises with elastic "rubber" band

Isometric resistance training

Harald Rief, MD, PhD

Jürgen Debus, MD, PhD

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-2 was designed to investigate the impact of tailored physical exercise in patients with unstable vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful unstable 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-2 was designed to investigate the impact of tailored physical exercise in patients with unstable vertebral metastases as compared to manual therapy (progressive muscle relaxation). 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 four 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 progressive muscle relaxation 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.

Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy

completion of all isometric exercises until 12 weeks post RT

PFS is assessed 2 years post completion of radiotherapy

FFS is assessed 2 years post completion of radiotherapy

bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine

pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation

Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment

Fatigue is assessed using the EORTC FA13 questionnaire

Heidelberg University

Musculoskeletal Diseases

Blood and Lymph Conditions

Bone Neoplasms

Bone Marrow Diseases

Bone Diseases

Hematologic Diseases

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.

exercise

Juergen Debus, MD PhD

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.

Isometric Muscle Training in Patients With Spinal Bony Metastases Under Radiation Therapy

Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy

safety and feasibility of isometric exercise in vertebral bony metastases

pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation therapy

Prof. Dr. Dr. J. Debus

intensity modulated radiotherapy (IMRT) 10 x 3 Gy

fractionated conventional external beam RT 10×3 Gy

Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis

IMRT

external beam Radiotherapy of the involved spinal bone metastasis

fractionated RT

The aim of this explorative trial is to verify the comparability of a fractionated intensity modulated radiotherapy with a conventional radiotherapy related to quality of life on the one hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as pain relief and local response for palliative patients with painful spinal bone metastases on the other hand. This is a single-center, prospective randomized controlled trial with parallel-group design to determine the quality of life after RT in patients with spinal bone metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT) and fractionated conventional external beam RT with 10×3 Gy each.

Experimental intervention:

IMRT 10 x 3 Gy

Control intervention:

3D-RT 10 x 3 Gy

The aim of this explorative trial is to verify the comparability of a fractionated intensity modulated radiotherapy with a conventional radiotherapy related to quality of life on the one hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as pain relief and local response for palliative patients with painful spinal bone metastases on the other hand. This is a single-center, prospective randomized controlled trial with parallel-group design to determine the quality of life after RT in patients with spinal bone metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT) and fractionated conventional external beam RT with 10×3 Gy each.

Experimental intervention:

IMRT 10 x 3 Gy

Control intervention:

3D-RT 10 x 3 Gy After the baseline measurements have been recorded, the patients will be randomly assigned to one of the two groups: IMRT 10×3 Gy (n = 30) or fractionated conventional 3D-RT 10×3 Gy (n = 30). The RT will be applied daily (mondy to Friday).

Follow-up per patient:

The target parameters will be measured and recorded at baseline, at the end of RT (t1), and at 12 weeks (t2) and 6 months (t3) after the end of the irradiation period.

Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases

improvement of more than 10% according to the EORTC BM22 questionaire measured at the 3-months-time-point after the end of RT (t2).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy	NCT02847754	Vertebral Bony ...	Isometric resis...	18 Years - 80 Years	Heidelberg University
Isometric Muscle Training in Patients With Spinal Bony Metastases Under Radiation Therapy	NCT01409720	Vertebral Bony ...	exercise	18 Years - 80 Years	Heidelberg University
Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases	NCT02832830	Vertebral Bony ...	IMRT fractionated RT	18 Years - 85 Years	Heidelberg University
Isometric Muscle Training in Patients With Spinal Bony Metastases Under Radiation Therapy	NCT01409720	Vertebral Bony ...	exercise	18 Years - 80 Years	Heidelberg University

Spots Global Cancer Trial Database for bony metastases