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

Quality of Life Clinical Trial

— RFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082314
• Other study ID #: RFA
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: October 12, 2016
• Start date: February 2014

Study information

• Verified date: October 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cementoplasty
• Neoplasms
• Quality of Life

Intervention

Procedure:
• RFA Vertebroplasty

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain response	To determine the complete and partial pain response rates in patients who undergo radiofrequency ablation (RFA) and/or cementoplasty/vertebroplasty for spinal/pelvic metastases.	Baseline to 6 weeks post treatment	No
Secondary	Functional Interference	To investigate how functional interference of pain changes	Baseline - 6 weeks post treatment	No
Secondary	Quality of Life	To investigate quality of life changes	Baseline - 6 weeks post treatment	No
Secondary	Side-effects	To investigate acute side effects of treatment	Baseline-6 weeks post treatment	No