Status:
COMPLETED
Non-Invasive Imaging for Cording in Breast Cancer Patients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 i...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Participants must be enrolled in Partners protocol # 2008P000540 "Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer"
- Confirmed case of cording by a medical provider (Physician, Nurse Practitioner, Physician Assistant)
- Participants must be at least 18 years of age
- Life expectancy of greater than 1 year.
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to comply with required follow up Perometer measurements and clinical visits.
Exclusion
- Participants who are not enrolled or have been removed from Partners Protocol # 2008P000540 will be excluded from this trial.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of prior surgery or radiation to the head, neck, upper limb, or trunk.
- Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01427166
Start Date
August 1 2011
End Date
August 1 2012
Last Update
March 16 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114