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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 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. |
|
| B | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise | Other | tailored isometric physical exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of isometric exercise in vertebral bony metastases | safety and feasibility of isometric exercise in vertebral bony metastases | 12 weeks post completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | PFS is assessed 2 years post completion of radiotherapy | 2 years post completion of radiotherapy |
| fracture-free survival (FFS) | FFS is assessed 2 years post completion of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juergen Debus, MD PhD | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Radiation Oncology, University of Heidelberg, Germany | Heidelberg | Germany | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15405683 | Background | ABRAMS HL, SPIRO R, GOLDSTEIN N. Metastases in carcinoma; analysis of 1000 autopsied cases. Cancer. 1950 Jan;3(1):74-85. doi: 10.1002/1097-0142(1950)3:13.0.co;2-7. No abstract available. | |
| 8433390 | Background | Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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 | 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 | 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 | 12 and 24 weeks post completion of therapy |
| Fatigue | Fatigue is assessed using the EORTC FA13 questionnaire | 12 and 24 weeks post completion of therapy |
| 3753707 | Background | Berrettoni BA, Carter JR. Mechanisms of cancer metastasis to bone. J Bone Joint Surg Am. 1986 Feb;68(2):308-12. No abstract available. |
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| Background | Hochschild J. Strukturen und Funktionen begreifen. Funktionelle Anatomie Band 1 und 2, Stuttgart: Thieme |
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| 27464793 | Derived | Rief H, Bruckner T, Schlampp I, Bostel T, Welzel T, Debus J, Forster R. Resistance training concomitant to radiotherapy of spinal bone metastases - survival and prognostic factors of a randomized trial. Radiat Oncol. 2016 Jul 27;11:97. doi: 10.1186/s13014-016-0675-x. |
| 26983672 | Derived | Rief H, Omlor G, Akbar M, Bruckner T, Rieken S, Forster R, Schlampp I, Welzel T, Bostel T, Roth HJ, Debus J. Biochemical markers of bone turnover in patients with spinal metastases after resistance training under radiotherapy--a randomized trial. BMC Cancer. 2016 Mar 17;16:231. doi: 10.1186/s12885-016-2278-1. |
| 25012645 | Derived | Rief H, Petersen LC, Omlor G, Akbar M, Bruckner T, Rieken S, Haefner MF, Schlampp I, Forster R, Debus J, Welzel T; German Bone Research Group. The effect of resistance training during radiotherapy on spinal bone metastases in cancer patients - a randomized trial. Radiother Oncol. 2014 Jul;112(1):133-9. doi: 10.1016/j.radonc.2014.06.008. Epub 2014 Jul 7. |
| 24998293 | Derived | Rief H, Akbar M, Keller M, Omlor G, Welzel T, Bruckner T, Rieken S, Hafner MF, Schlampp I, Gioules A, Debus J. Quality of life and fatigue of patients with spinal bone metastases under combined treatment with resistance training and radiation therapy- a randomized pilot trial. Radiat Oncol. 2014 Jul 7;9:151. doi: 10.1186/1748-717X-9-151. |
| 24996223 | Derived | Rief H, Welzel T, Omlor G, Akbar M, Bruckner T, Rieken S, Haefner MF, Schlampp I, Gioules A, Debus J. Pain response of resistance training of the paravertebral musculature under radiotherapy in patients with spinal bone metastases--a randomized trial. BMC Cancer. 2014 Jul 5;14:485. doi: 10.1186/1471-2407-14-485. |
| 24917420 | Derived | Rief H, Heinhold M, Bruckner T, Schlampp I, Forster R, Welzel T, Bostel T, Debus J, Rieken S; German Bone Research Group. Quality of life, fatigue and local response of patients with unstable spinal bone metastases under radiation therapy--a prospective trial. Radiat Oncol. 2014 Jun 11;9:133. doi: 10.1186/1748-717X-9-133. |
| 24499460 | Derived | Rief H, Omlor G, Akbar M, Welzel T, Bruckner T, Rieken S, Haefner MF, Schlampp I, Gioules A, Habermehl D, von Nettelbladt F, Debus J. Feasibility of isometric spinal muscle training in patients with bone metastases under radiation therapy - first results of a randomized pilot trial. BMC Cancer. 2014 Feb 5;14:67. doi: 10.1186/1471-2407-14-67. |
| 22070722 | Derived | Rief H, Jensen AD, Bruckner T, Herfarth K, Debus J. Isometric muscle training of the spine musculature in patients with spinal bony metastases under radiation therapy. BMC Cancer. 2011 Nov 9;11:482. doi: 10.1186/1471-2407-11-482. |