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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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-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.


Detailed 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-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.


Sponsor: Heidelberg University

Current Primary Outcome: feasibility of isometric exercise in unstable vertebral bony metastases [ Time Frame: 12 weeks post completion of radiotherapy ]

completion of all isometric exercises until 12 weeks post RT


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • progression-free survival (PFS) [ Time Frame: 2 years post completion of radiotherapy ]
    PFS is assessed 2 years post completion of radiotherapy
  • fracture-free survival (FFS) [ Time Frame: 2 years post completion of radiotherapy ]
    FFS is assessed 2 years post completion of radiotherapy
  • bone density [ 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
  • pain reduction [ Time Frame: Immediately after completion of radiotherapy, 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
  • Quality of life [ 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
  • Fatigue [ Time Frame: 12 and 24 weeks post completion of therapy ]
    Fatigue is assessed using the EORTC FA13 questionnaire


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: July 12, 2016
Date Started: August 2016
Date Completion: January 2020
Last Updated: July 25, 2016
Last Verified: July 2016