Pelvic Fractures and Radiation Therapy for Cervical Cancer
The goal of this study is to estimate how often pelvic fractures occur in women treated with radiation therapy for either newly diagnosed or recurrent cervical, endometrial, or vaginal cancer. The study will also estimate the changes in bone mineral density and the changes in the blood that relate to "bone turnover". High bone turnover can weaken bones and make you more likely to break a bone.
Procedure: CT or MRI + Blood Test
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer|
- Change in Patient Bone Mineral Density (BMD) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Incidence of pelvic fractures incidence in women treated with definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer [ Time Frame: Within 2 years of treatment completion ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Bone Mineral Density Test + MRI or CT + Blood Test
Procedure: CT or MRI + Blood Test
During routine visits, a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
Blood (about 1 tablespoon) will be drawn to test for bone turnover.
If you agree to take part in this study, the following tests and procedures will be performed before radiation therapy, 4 weeks after start of radiation therapy, and 3 months, 1 year, and 2 years after you complete radiation:
- You will have a bone mineral density test. A bone mineral density test measures bone loss over time, identifies osteoporosis (a disease of the bones that causes them to be weak and easily breakable) or the risk for developing osteoporosis, and checks your risk for fractures. During the test, you will lie on a cushioned table while a mechanical arm-like device will pass over your body. This device will not touch you.
- During your routine visits, you may have either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan of the pelvis as part of your standard of care. A PET scan may be done if your doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine your response to therapy, determine if your cancer has returned, and to look for broken bones.
- Blood (about 1 tablespoon) will be drawn to test for bone turnover.
- Before you start treatment, blood (about 2 to 3 teaspoons) will be drawn for tests to measure the level of vitamin D, calcium, phosphorus, and parathyroid hormone (PTH).
When you join the study, researchers will collect information from your medical record. This information will include your medical history, your ethnicity, if you have had any bone fractures, if you have a history of bone fractures in your family, and your use of tobacco and/or alcohol.
Length of Study:
You will be off study 2 years after you complete radiation.
This is an investigational study.
Up to 300 women will take part in the study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800644
|Contact: Kathleen Schmeler||713-745-3518|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Kathleen Schmeler, MD|
|Principal Investigator:||Kathleen Schmeler, MD||M.D. Anderson Cancer Center|