- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202046
Predictors of Lymphedema Following Breast Cancer Surgery
December 2, 2015 updated by: HealthPartners Institute
The purpose of this study evaluate which factors play a role in lymphedema development among women who have had axillary surgery for breast cancer.
Potential risk factors for women who have developed lymphedema will be compared to risk factors among women who have not developed lymphedema after breast cancer surgery.
Study Overview
Status
Completed
Conditions
Detailed Description
Surgery for breast cancer includes removal of the breast tumor along with the axillary lymph nodes.
The status of these nodes helps clinicians determine prognosis and guides treatment decisions.
Unfortunately, a relatively common side effect following axillary lymph node dissection is upper-extremity lymphedema.
The purpose of this study is to identify risk factors for lymphedema among women who have had axillary surgery for breast cancer.
Specific aims include identifying risk factors for lymphedema and comparing quality of life (QOL) ratings for women who have and do not have lymphedema.
A case-control study will be conducted with enrollment of 200 participants.
Cases will be identified at their lymphedema consult in the physical therapy centers.
Using the oncology registry, controls will include patients who have had breast cancer surgery and have not developed lymphedema.
The severity of lymphedema and interference with daily life will be assessed with the Measure of Arm Symptom Survey (MASS), a patient-completed survey, and QOL will be collected with the SF-36.
Treatment risk factors including previous surgery, radiotherapy and chemotherapy will be obtained from oncology registry data.
This study will determine which factors play a role in lymphedema development.
Study Type
Observational
Enrollment (Actual)
188
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55422
- North Memorial Medical Center
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Minneapolis, Minnesota, United States, 55455
- Fairview University
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St. Louis Park, Minnesota, United States, 55416
- Park Nicollet Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with upper-extremety lymphedema(prevalent and incident cases) are identified at the time they presented to the physical therapy department or cancer center at 5 participating institutions (Park Nicollet health Services, fairview-University Medical Center, Fairview Southdale medical Center, North Memorial medical Center, and healthEast Care System).
Controls were identified through the oncology Registry.
Description
Inclusion Criteria:
- Clinical diagnosis of lymphedema
- Axillary node surgery by sentinel node or axillary node dissection
- No known metastatic disease in the axilla
- Able and willing to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with lymphedema
Identification of risk factors for lymphedema in women who have had axillary surgery for breast cancer.
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Control patients without lymphedema
Controls matched on type of axillary surgery and surgery date for comparison in quality of life (QOL) ratings from women who have lymphedema.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen K Swenson, RN, MS, PhDc, HealthPartners Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1728-03-B
- DAMD17-03-0738
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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