Clinical trial NCT02082314: Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty
Official title: Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Cementoplasty
Quality of Life
Keywords: radiofrequency ablation
bone metastases
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be derived from patients with advanced cancers with spinal/pelvic metastases who have been referred to interventional radiology and have consented to receiving RFA and/or cementoplasty for their disease. Such patients will be followed with a daily diary for 10 days after treatment. The Brief Pain Inventory will be used to assess pain and functional interference on these days.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Pain response
timeFrame: Baseline to 6 weeks post treatment
Secondary outcomes:
measure: Functional Interference
timeFrame: Baseline - 6 weeks post treatment
measure: Quality of Life
timeFrame: Baseline - 6 weeks post treatment
measure: Side-effects
timeFrame: Baseline-6 weeks post treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Elizabeth David, MD
role: PRINCIPAL_INVESTIGATOR
References: