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Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer

This study is ongoing, but not recruiting participants.

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   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 1997

Detailed Description:

OBJECTIVES:

  • Compare high vacuum drainage vs low vacuum drainage vs simple tube drainage in patients undergoing axillary surgery for stage I or II breast cancer.

OUTLINE: This is a randomized study.

Patients undergo axillary dissection, then are randomized to one of three axillary drainage systems.

  • Arm I: Patients receive high vacuum drainage.
  • Arm II: Patients receive low vacuum drainage.
  • Arm III: Patients receive simple tube drainage (no vacuum). All drains are removed when daily volumes are below 30 mL or at 5 days after surgery, regardless of drain volume.

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of resectable stage I or II breast cancer
  • Planned primary surgery of level II or III axillary dissection in association with one of the following:

    • Wide local excision (may be done through separate incision)
    • No breast surgery
    • Bilateral surgery allowed
  • No prior mastectomy
  • No immediate breast reconstruction using implants, latissimus dorsi, or rectus abdominus myocutaneous flaps at primary operation
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  • No prior axillary surgery
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005600

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

Sponsors and Collaborators
Royal Marsden - London

Investigators
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  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer  
stage II breast cancer  
lymphedema  
perioperative/postoperative complications  

Study placed in the following topic categories:
Lymphedema
Skin Diseases
Postoperative Complications
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on December 03, 2008




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