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Predictors of Lymphedema Following Breast Cancer Surgery

NCT ID: NCT00202046

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Lymphedema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with lymphedema

Identification of risk factors for lymphedema in women who have had axillary surgery for breast cancer.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen K Swenson, RN, MS, PhDc

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

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North Memorial Medical Center

Minneapolis, Minnesota, United States

Site Status

Fairview University

Minneapolis, Minnesota, United States

Site Status

Park Nicollet Institute

Saint Louis Park, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19273407 (View on PubMed)

Other Identifiers

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DAMD17-03-0738

Identifier Type: -

Identifier Source: secondary_id

1728-03-B

Identifier Type: -

Identifier Source: org_study_id