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| Sponsored by: |
Royal Marsden - London |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005600 |
Purpose
RATIONALE: The use of axillary drains may help to prevent complications following axillary lymph node dissection.
PURPOSE: This randomized clinical trial is comparing three methods of axillary drainage to see how well they work following lymph node dissection in women with stage I or stage II breast cancer.
| Condition | Intervention |
|
Breast Cancer Cancer-Related Problem/Condition |
Procedure: management of therapy complications |
| Genetics Home Reference related topics: | breast cancer lymphedema-distichiasis syndrome |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| Official Title: | Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study |
| Study Start Date: | November 1997 |
OBJECTIVES:
OUTLINE: This is a randomized study.
Patients undergo axillary dissection, then are randomized to one of three axillary drainage systems.
Patients are followed at day 10 and at 3 months.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planned primary surgery of level II or III axillary dissection in association with one of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United Kingdom, England | |||||
| Royal Marsden NHS Foundation Trust - London | |||||
| London, England, United Kingdom, SW3 6JJ | |||||
| Royal Marsden NHS Foundation Trust - Surrey | |||||
| Sutton, England, United Kingdom, SM2 5PT | |||||
| Royal Marsden - London |
| Study Chair: | Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) | Royal Marsden - London |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067713, RMNHS-1489, EU-20004 |
| First Received: | May 2, 2000 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005600 |
| Health Authority: | United States: Federal Government |
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