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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409720
First Posted: August 4, 2011
Last Update Posted: March 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • feasibility of isometric exercise in vertebral bony metastases [ Time Frame: 12 weeks post completion of radiotherapy ]
    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 ]
    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: end of treatment, 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 therapy

  • 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


Estimated Enrollment: 60
Study Start Date: September 2011
Study Completion Date: September 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409720


Locations
Germany
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Juergen Debus, MD PhD Heidelberg University
  More Information

Publications:
ABRAMS HL, SPIRO R, GOLDSTEIN N. Metastases in carcinoma; analysis of 1000 autopsied cases. Cancer. 1950 Jan;3(1):74-85.
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.
Berrettoni BA, Carter JR. Mechanisms of cancer metastasis to bone. J Bone Joint Surg Am. 1986 Feb;68(2):308-12.
Bubendorf L, Schöpfer 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.
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.
Harrington KD. Impending pathologic fractures from metastatic malignancy: evaluation and management. Instr Course Lect. 1986;35:357-81.
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.
Nikander R, Sievänen 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.
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.
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. Review.
Stevinson C, Fox KR. Feasibility of an exercise rehabilitation programme for cancer patients. Eur J Cancer Care (Engl). 2006 Sep;15(4):386-96.
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Rief H, Bruckner T, Schlampp I, Bostel T, Welzel T, Debus J, Förster 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.
Rief H, Omlor G, Akbar M, Bruckner T, Rieken S, Förster 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.
Rief H, Petersen LC, Omlor G, Akbar M, Bruckner T, Rieken S, Haefner MF, Schlampp I, Förster 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.
Rief H, Akbar M, Keller M, Omlor G, Welzel T, Bruckner T, Rieken S, Häfner 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.
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.
Rief H, Heinhold M, Bruckner T, Schlampp I, Förster 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.
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.
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.

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
First Submitted: August 2, 2011
First Posted: August 4, 2011
Last Update Posted: March 20, 2014
Last Verified: August 2011

Keywords provided by Heidelberg University:
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


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