Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

University of Arizona11 enrolled

Overview

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Cancers Multiple Myeloma Vertebral Fracture

Interventions

VertebroplastyPROCEDURE

Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.

RadiotherapyRADIATION

Radiotherapy of metastatic lesions to the spine.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Arizona

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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