Condition category
Cancer
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
26/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Edwin van der Linden

ORCID ID

Contact details

Department of Radiology Hs-220
Erasmus MC - University Medical Center Rotterdam
's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)10 463 2886
e.vanderlinden@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CCMO NL14746.078.07; Erasmus MC METC 2007-033

Study information

Scientific title

Acronym

VERAMM

Study hypothesis

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

The VERAMM trial was approved by the Medical Ethics Committee Erasmus MC (METC) on the 15th March 2007 (ref: MEC-2007-033).

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Spinal metastases, vertebroplasty, multiple myeloma

Intervention

Arm I (control): radiotherapy (20 Gy) of affected vertebrae
Arm II: vertebroplasty of affected vertebrae

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

04/06/2007

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

104

Participant 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)

Recruitment start date

04/06/2007

Recruitment end date

01/03/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Radiology Hs-220
Rotterdam
3015 CE
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Radiology
’s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes