Metastatic Cancers, Multiple Myeloma, Vertebral Fracture
Conditions
Keywords
vertebral bodies, vertebral fracture, vertebral augmentation, radiotherapy, vertebroplasty, kyphoplasty
Brief summary
Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.
Detailed description
The study quantifies the reduction of pain and changes in quality of life associated with vertebral augmentation. This study is conducted in patients with metastatic cancer or multiple myeloma involving the spine. This study addresses the value of vertebral augmentation in combination with radiotherapy in the setting of cancer to the spine. The patient's pain, overall quality of life, and fracture development/avoidance will be compared to patients treated only with radiotherapy in the past.
Interventions
PROCEDUREVertebroplasty
Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
RADIATIONRadiotherapy
Radiotherapy of metastatic lesions to the spine.
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of metastatic disease to the vertebra or multiple myeloma * Negative pregnancy test within 2 weeks prior to registration * Life expectancy of \>= 3 months and Karnofsky performance status (KPS) score \>= 40 * Pain scale score \>=5 * Pain at involved vertebral body not adequately controlled * Osteolysis of vertebral bodies * Must agree to practice adequate means of birth control * Must sign informed consent prior to study entry * Must be able to understand the English language * Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule.
Exclusion criteria
* Spinal Cord Compression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study. | 14 weeks | Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include: \- Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS) | 14 weeks | Roland-Morris Disability Questionnaire - The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 (best) to a maximum of 24 (worst). Karnofsky Performance Status (KPS) - scale from 10 (moribund, fatal processes progressing rapidly) to 100 (normal, no complaints, no evidence of disease). |
| Quality of Life Assessment From the EORTC QLQ C30 Questionnaire. | 14 weeks | EORTC QLQ-C30 (version 3) - The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning,a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems. |
| Fracture Rates Detected From X-rays. | 14 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vertebroplasty With Radiotherapy Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.
Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
Radiotherapy: Radiotherapy of metastatic lesions to the spine. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Vertebroplasty With Radiotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 10 |
| other Total, other adverse events | 5 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
Primary
Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include: \- Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments
Time frame: 14 weeks
Population: Study terminated when PI left institution; data not collected.
Secondary
Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)
Roland-Morris Disability Questionnaire - The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 (best) to a maximum of 24 (worst). Karnofsky Performance Status (KPS) - scale from 10 (moribund, fatal processes progressing rapidly) to 100 (normal, no complaints, no evidence of disease).
Time frame: 14 weeks
Population: Study terminated when PI left institution; data not collected.
Secondary
Fracture Rates Detected From X-rays.
Time frame: 14 weeks
Population: Study terminated when PI left institution; data not collected.
Secondary
Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.
EORTC QLQ-C30 (version 3) - The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning,a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: 14 weeks
Population: Study terminated when PI left institution; data not collected.