Prospective Study Determining the Pain Response, Function... | NCT02082314

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Not provided

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Mar 7, 2014

First Posted Date

Mar 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
RFA Vertebroplasty	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Functional Interference	To investigate how functional interference of pain changes	Baseline - 6 weeks post treatment
Quality of Life	To investigate quality of life changes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Elizabeth David, MD	Sunnybrook Health Sciences Centre	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre		Toronto	Ontario	M4N 3M5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided