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

This study is not yet open for participant recruitment.
Verified August 2011 by University of Heidelberg
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01409720
First received: August 2, 2011
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Vertebral Bony Metastases
 Other: exercise
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • feasibility of isometric exercise in vertebral bony metastases [ Time Frame: 12 weeks post completion of radiotherapy ] [ Designated as safety issue: Yes ]
    safety and feasibility of isometric exercise in vertebral bony metastases


Secondary Outcome Measures:
  • progression-free survival (PFS) [ Time Frame: 2 years post completion of radiotherapy ] [ Designated as safety issue: No ]
    PFS is assessed 2 years post completion of radiotherapy

  • fracture-free survival (FFS) [ Time Frame: 2 years post completion of radiotherapy ] [ Designated as safety issue: No ]
    FFS is assessed 2 years post completion of radiotherapy

  • bone density [ Time Frame: 12 weeks post completion radiotherapy ] [ Designated as safety issue: No ]
    bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine

  • pain reduction [ Time Frame: end of treatment, 12 and 24 weeks post completion of radiotherapy ] [ Designated as safety issue: No ]
    pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation therapy

  • Quality of life [ Time Frame: 12 and 24 weeks post completion of therapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Fatigue is assessed using the EORTC FA13 questionnaire


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Other: exercise
tailored isometric physical exercise
No Intervention: B
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409720

Contacts
Contact: Harald Rief, MD +49-6221-56 ext 8202 harald.rief@med.uni-heidelberg.de
Contact: Juergen Debus, MD PhD +49-6221-56 ext 8202 juergen.debus@med.uni-heidelberg.de

Locations
Germany
Dept of Radiation Oncology, University of Heidelberg, Germany Not yet recruiting
Heidelberg, Germany, 69120
Contact: Harald Rief, MD     +49-6221-56´- ext 8202     harald.rief@med.uni-heidelberg.de    
Sub-Investigator: Harald Rief, MD            
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Juergen Debus, MD PhD University of Heidelberg
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Dr. J. Debus, Dept of Radiation Oncology, University of Heidelberg, Germany
ClinicalTrials.gov Identifier: NCT01409720     History of Changes
Other Study ID Numbers: DISPO
Study First Received: August 2, 2011
Last Updated: August 3, 2011
Health Authority: University of Heidelberg, Germany: Ethics committee

Keywords provided by University of Heidelberg:
bony metastases
physical exercise

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
 Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013