NCT00202046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 3, 2015

Status Verified

April 1, 2007

Enrollment Period

5.3 years

First QC Date

September 13, 2005

Last Update Submit

December 2, 2015

Conditions

Keywords

Breast cancerLymphedemaQuality of life

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

North Memorial Medical Center

Minneapolis, Minnesota, 55422, United States

Location

Fairview University

Minneapolis, Minnesota, 55455, United States

Location

Park Nicollet Institute

Saint Louis Park, Minnesota, 55416, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Karen K Swenson, RN, MS, PhDc

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 3, 2015

Record last verified: 2007-04

Locations