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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

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 20, 2005
Last Update Posted Date December 3, 2015
Study Start Date January 2003
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00202046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictors of Lymphedema Following Breast Cancer Surgery
Official Title Predictors of Lymphedema Following Breast Cancer Surgery
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.
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
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Breast Cancer
  • Lymphedema
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Swenson KK, Nissen MJ, Leach JW, Post-White J. Case-control study to evaluate predictors of lymphedema after breast cancer surgery. Oncol Nurs Forum. 2009 Mar;36(2):185-93. doi: 10.1188/09.ONF.185-193.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 10, 2015)
188
Original Enrollment
 (submitted: September 13, 2005)
200
Actual Study Completion Date May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00202046
Other Study ID Numbers 1728-03-B
DAMD17-03-0738
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party HealthPartners Institute
Study Sponsor HealthPartners Institute
Collaborators U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Karen K Swenson, RN, MS, PhDc HealthPartners Institute
PRS Account HealthPartners Institute
Verification Date April 2007