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Vertebral Bony MetastasesPhase 2DISPONCT01409720

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

A Phase 2 study testing exercise in people with Vertebral Bony Metastases, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Vertebral Bony Metastases
What is being tested?
exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGermany
Study dates
Sep 2011to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Dept of Radiation Oncology, University of Heidelberg, Germany

    Heidelberg, Germany, 69120

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
exercise
Keywords
bony metastases, physical exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exerciseOther

    tailored isometric physical exercise

Study groups in NCT01409720
Study groupRoleWhat they receive
AExperimentalpatients 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.
Receives: Other: exercise
BNo interventionPatients in arm B (control group) receive 10 daily sessions of 15 min manual therapy (i.e. massage, etc) starting from day one of radiotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. feasibility of isometric exercise in vertebral bony metastases

    safety and feasibility of isometric exercise in vertebral bony metastases

    Measured: 12 weeks post completion of radiotherapy

Secondary outcomes (6)

  1. progression-free survival (PFS)

    PFS is assessed 2 years post completion of radiotherapy

    Measured: 2 years post completion of radiotherapy

  2. fracture-free survival (FFS)

    FFS is assessed 2 years post completion of radiotherapy

    Measured: 2 years post completion of radiotherapy

  3. bone density

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

    Measured: 12 weeks post completion radiotherapy

  4. pain reduction

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

    Measured: end of treatment, 12 and 24 weeks post completion of radiotherapy

  5. Quality of life

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

    Measured: 12 and 24 weeks post completion of therapy

  6. Fatigue

    Fatigue is assessed using the EORTC FA13 questionnaire

    Measured: 12 and 24 weeks post completion of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2012
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01409720
Sponsor's protocol ID
DISPO
Acronym
DISPO
Status last verified
Aug 2011
First submitted
2 Aug 2011
Last updated
20 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15405683

  • 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.

    PubMed 8433390

  • Berrettoni BA, Carter JR. Mechanisms of cancer metastasis to bone. J Bone Joint Surg Am. 1986 Feb;68(2):308-12. No abstract available.

    PubMed 3753707

  • Bubendorf L, Schopfer A, Wagner U, Sauter G, Moch H, Willi N, Gasser TC, Mihatsch MJ. Metastatic patterns of prostate cancer: an autopsy study of 1,589 patients. Hum Pathol. 2000 May;31(5):578-83. doi: 10.1053/hp.2000.6698.

    PubMed 10836297

  • Cheville AL, Girardi J, Clark MM, Rummans TA, Pittelkow T, Brown P, Hanson J, Atherton P, Johnson ME, Sloan JA, Gamble G. Therapeutic exercise during outpatient radiation therapy for advanced cancer: Feasibility and impact on physical well-being. Am J Phys Med Rehabil. 2010 Aug;89(8):611-9. doi: 10.1097/PHM.0b013e3181d3e782.

    PubMed 20531162

  • Harrington KD. Impending pathologic fractures from metastatic malignancy: evaluation and management. Instr Course Lect. 1986;35:357-81.

    PubMed 3819423

  • Hochschild J. Strukturen und Funktionen begreifen. Funktionelle Anatomie Band 1 und 2, Stuttgart: Thieme

  • Krempien B. Die Entstehung von Knochenschmerzen bei Knochenmetastasen und ihre Behandlung durch Bisphosphonate. Hrsg: Bartsch HH, Hornstein W: Interdisziplinäre Schmerztherapie bei Tumorpatienten, 1998

  • Murnane A, Geary B, Milne D. The exercise programming preferences and activity levels of cancer patients undergoing radiotherapy treatment. Support Care Cancer. 2012 May;20(5):957-62. doi: 10.1007/s00520-011-1167-z. Epub 2011 Apr 27.

    PubMed 21523349

  • Nikander R, Sievanen H, Ojala K, Oivanen T, Kellokumpu-Lehtinen PL, Saarto T. Effect of a vigorous aerobic regimen on physical performance in breast cancer patients - a randomized controlled pilot trial. Acta Oncol. 2007;46(2):181-6. doi: 10.1080/02841860600833145.

    PubMed 17453366

  • Pilge H, Holzapfel BM, Prodinger PM, Hadjamu M, Gollwitzer H, Rechl H. [Diagnostics and therapy of spinal metastases]. Orthopade. 2011 Feb;40(2):185-93; quiz 194-5. doi: 10.1007/s00132-010-1738-6. German.

    PubMed 21271338

  • Roe JW, Ashforth KM. Prophylactic swallowing exercises for patients receiving radiotherapy for head and neck cancer. Curr Opin Otolaryngol Head Neck Surg. 2011 Jun;19(3):144-9. doi: 10.1097/MOO.0b013e3283457616.

    PubMed 21430531

  • Stevinson C, Fox KR. Feasibility of an exercise rehabilitation programme for cancer patients. Eur J Cancer Care (Engl). 2006 Sep;15(4):386-96. doi: 10.1111/j.1365-2354.2006.00677.x.

    PubMed 16968322

  • Verger E, Salamero M, Conill C. Can Karnofsky performance status be transformed to the Eastern Cooperative Oncology Group scoring scale and vice versa? Eur J Cancer. 1992;28A(8-9):1328-30. doi: 10.1016/0959-8049(92)90510-9.

    PubMed 1515244

  • Zhong H, De Marzo AM, Laughner E, Lim M, Hilton DA, Zagzag D, Buechler P, Isaacs WB, Semenza GL, Simons JW. Overexpression of hypoxia-inducible factor 1alpha in common human cancers and their metastases. Cancer Res. 1999 Nov 15;59(22):5830-5.

    PubMed 10582706

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing exercise in people with Vertebral Bony Metastases, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

feasibility of isometric exercise in vertebral bony metastases (time frame: 12 weeks post completion of radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01409720, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.

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