VErtebroplasty versus Radiotherapy As palliative treatment of vertebral metastases of Multiple Myeloma (M. Kahler)

ISRCTN	ISRCTN48083859
DOI	https://doi.org/10.1186/ISRCTN48083859
Secondary identifying numbers	CCMO NL14746.078.07; Erasmus MC METC 2007-033

Submission date: 27/06/2007
Registration date: 27/06/2007
Last edited: 26/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Edwin van der Linden
Scientific

Department of Radiology Hs-220
Erasmus MC - University Medical Center Rotterdam
's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Phone	+31 (0)10 463 2886
Email	e.vanderlinden@erasmusmc.nl

Study information

Study design	Randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	VERAMM
Study objectives	Vertebroplasty improves the quality of life of the individual patient by increased pain reduction and restoration of mobility. Vertebroplasty also reduces costs, as it decreases the number of inpatient days, the number of outpatient visits and follow-up treatments, and the need for home care.
Ethics approval(s)	The VERAMM trial was approved by the Medical Ethics Committee Erasmus MC (METC) on the 15th March 2007 (ref: MEC-2007-033).
Health condition(s) or problem(s) studied	Spinal metastases, vertebroplasty, multiple myeloma
Intervention	Arm I (control): radiotherapy (20 Gy) of affected vertebrae Arm II: vertebroplasty of affected vertebrae
Intervention type	Other
Primary outcome measure	1. Degree of pain (VAS-pain score, scale: 0 - 10), measured at day 0 (pre-treatment), day 0 (post-treatment), day 7, week 4, week 12, month 6 and year 1 2. Use of pain medication, measured at day 0 (pre-treatment), day 0 (post-treatment), day 7, week 4, week 12, month 6 and year 1
Secondary outcome measures	1. Initial technical success and complications, measured at day 0 (post-treatment) and week 4 respectively 2. Mobility (Oswestry-daily activity scale), measured at day 0 (pre-treatment), day 7, week 4, week 12, month 6 and year 1 3. Quality of life (questionnaires: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire on Myeloma [EORTC QLQ-MY24], 36-item Short Form health survey [SF-36]), measured at day 0 (pre-treatment), day 7, week 4, week 12, month 6 and year 1 4. Collapse of treated vertebrae (lateral X-WK), measured at day 0 (pre-treatment), week 4, week 12, month 6 and year 1 5. Mortality, measured at year 1 6. Direct medical costs (e.g. procedure costs, hospitalisation days, pain medication, secondary interventions, revalidation or nursing home costs, follow-up), measured at year 1
Overall study start date	04/06/2007
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	104
Key inclusion criteria	1. Persistent pain caused by vertebral metastases from myeloma (including plasmacytoma) with Visual Analogue Scale (VAS) score greater than 4 (scale: 1-10) 2. Informed consent 3. Older than 18 years
Key exclusion criteria	1. Greater than four affected vertebrae 2. Vertebral fracture through back wall with retropulsion that consumes more than 33% of the spinal channel 3. Myelum compression with neurological degeneration: Frankel A/B 4. Epiduritis 5. Incorrigible coagulopathy 6. Karnofsky score less than 30 (moribund)
Date of first enrolment	04/06/2007
Date of final enrolment	01/03/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Radiology Hs-220

Rotterdam
3015 CE
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

Department of Radiology
s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Website	http://www.erasmusmc.nl/content/englishindex.htm
"ROR"	https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan