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

Vertebral Bony Metastases Clinical Trial

— DISPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409720
• Other study ID #: DISPO
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2011
• Last updated: March 19, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2011
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: University of Heidelberg, Germany: Ethics committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Neoplasm Metastasis
• Vertebral Bony Metastases

Intervention

Other:
• exercise
tailored isometric physical exercise

Locations

Country	Name	City	State
Germany	Dept of Radiation Oncology, University of Heidelberg, Germany	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (15)

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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. — View Citation

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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. — View Citation

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. — View Citation

Stevinson C, Fox KR. Feasibility of an exercise rehabilitation programme for cancer patients. Eur J Cancer Care (Engl). 2006 Sep;15(4):386-96. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of isometric exercise in vertebral bony metastases	safety and feasibility of isometric exercise in vertebral bony metastases	12 weeks post completion of radiotherapy	Yes
Secondary	progression-free survival (PFS)	PFS is assessed 2 years post completion of radiotherapy	2 years post completion of radiotherapy	No
Secondary	fracture-free survival (FFS)	FFS is assessed 2 years post completion of radiotherapy	2 years post completion of radiotherapy	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Fatigue	Fatigue is assessed using the EORTC FA13 questionnaire	12 and 24 weeks post completion of therapy	No