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Completed

NCT Number: NCT02082314

Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty

Bone metastases are a cause of significant morbidity in cancer patients. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death (1). These metastases frequently give rise to complications that reduce patients' quality of life. These include: pain, fractures, and decreased mobility, ultimately reducing performance status.

Radiofrequency ablation therapy with cementoplasty/vertebroplasty for painful bone metastases has been shown to be feasible, efficacious, and safe. However, patient reported outcomes have yet to be determined.

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Key information

Conditions

Neoplasms Cementoplasty Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically proven malignancy.
  • Patients aged 18 and above.
  • Advanced cancer with bone metastasis(es) to the spine and/or pelvis
  • Symptomatic with axial pain from spinal lesions and at risk for pathological fracture, or, pathological fracture without spinal cord compromise
  • Karnofsky Performance Status (KPS) greater than or equal to 40 at the time of baseline evaluation.
  • Is planned to receive RFA and/or cementoplasty with treatment to all sites being followed for study.
  • Is able to provide worst pain score at bony metastatic site(s).
  • Patient is able and willing to fill out daily diary.
  • Patients must be able to provide informed consent prior to being enrolled to the study.

Exclusion criteria

  • Progressive neurological compromise
  • Pathological fracture of vertebrae with significant cortical involvement or spinal canal compromise
  • Central nervous system metastases
  • Inability to record pain score, complete diary and communicate this to study personnel.

Treatment and study plan

RFA Vertebroplasty

Procedure

Primary outcomes

  1. Pain response

    Time frame: Baseline to 6 weeks post treatment

    To determine the complete and partial pain response rates in patients who undergo radiofrequency ablation (RFA) and/or cementoplasty/vertebroplasty for spinal/pelvic metastases.

Secondary outcomes

  1. Functional Interference

    Time frame: Baseline - 6 weeks post treatment

    To investigate how functional interference of pain changes

  2. Quality of Life

    Time frame: Baseline - 6 weeks post treatment

    To investigate quality of life changes

  3. Side-effects

    Time frame: Baseline-6 weeks post treatment

    To investigate acute side effects of treatment

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Acronym: RFA

Important dates

Study start
2014
Primary completion
2016
First posted
Mar 10, 2014
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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