Non-Invasive Imaging for Cording in Breast Cancer Patients
To date, the scientific literature has yet to provide sufficient evidence regarding the pathophysiology of cording. The objective of this protocol is to evaluate the utility of non invasive vascular imaging for assessing the pathophysiology of cording in a small study cohort of patients who were treated for breast cancer. The hypothesis is that cording may have a vascular etiology
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Non Invasive Imaging for Assessing the Pathophysiology of Cording in Patients Treated for Breast Cancer|
- The pathophysiology of cording following treatment for breast cancer [ Designated as safety issue: No ]The cohort of 15 subject's images will be reviewed by the PI and a designated physician from the department of vascular medicine to determine if there is a vascular origin in the cords. Each image will be accessed for the following findings or involvement: Venous, lymphatic, fluid pockets, and striations on the cord.
- Cording and the onset of breast cancer related lymphedema [ Designated as safety issue: No ]Subjects will be measured every 4-7 months with a perometer to determine if breast cancer related lymphedema is present.
|Study Start Date:||August 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Other: Non invasive venous ultrasound
Cords are bands of tissue that are present in the axilla following breast cancer surgery and may extend across the antecubital fossa and into the forearm. Cords are often painful to patients and limit their shoulder range of motion.The proposed study design involves the recruitment of patients who are enrolled in Partners Protocol # 2008P000540, a prospective analysis of symptoms, functionality and quality of life questionnaire to evaluate lymphedema in patients following treatment for breast cancer. This protocol recruits newly diagnosed breast cancer patients prior to any treatment interventions. Subjects are required to undergo volumetric arm measurements and complete the Lymphedema Evaluation Following Treatment for Breast Cancer Questionnaire (LEFT-BC) which will allow for the evaluation of changes in functionality, upper extremity utilization (fear associated avoidance), and quality of life. Throughout treatment patients will be screened before and after each treatment event: surgery, chemotherapy and radiation. Following the conclusion of treatment for breast cancer, patients will be measured at least 2 times per year (every 4-7 months). If during these study visits the patient notes cording symptoms, the research staff administering the questionnaire will be alerted. At this point, they will notify a designated medical provider who will perform a physical examination of the area to confirm the presence of cording. Once the presence of cording is verified, the patient will be provided with the opportunity to enroll in the proposed trial. Due to the current limited knowledge on the nature of the condition, the patients arm and axilla will have to be imaged within 7 days of the physical exam confirmation. The patients will be asked to return to the vascular imaging lab located on the Massachusetts's General Hospital's main campus. They will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a Phillips-IU-22 probe.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427166
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Alphonse G Taghian, MD PhD||Massachusetts General Hospital|