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Predictors of Lymphedema Following Breast Cancer Surgery

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ClinicalTrials.gov Identifier: NCT00202046
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
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.

Condition or disease
Breast Cancer Lymphedema

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
Actual Enrollment : 188 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Predictors of Lymphedema Following Breast Cancer Surgery
Study Start Date : January 2003
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Patients with lymphedema
Identification of risk factors for lymphedema in women who have had axillary surgery for breast cancer.
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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202046


Locations
United States, Minnesota
North Memorial Medical Center
Minneapolis, Minnesota, United States, 55422
Fairview University
Minneapolis, Minnesota, United States, 55455
Park Nicollet Institute
St. Louis Park, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Karen K Swenson, RN, MS, PhDc HealthPartners Institute

Publications:
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00202046     History of Changes
Other Study ID Numbers: 1728-03-B
DAMD17-03-0738
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: April 2007

Keywords provided by HealthPartners Institute:
Breast cancer
Lymphedema
Quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases