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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005600
First received: May 2, 2000
Last updated: May 9, 2009
Last verified: December 2005
History of Changes

May 2, 2000
May 9, 2009
November 1997
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Complete list of historical versions of study NCT00005600 on ClinicalTrials.gov Archive Site
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Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study

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.

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.
Interventional
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Allocation: Randomized
Primary Purpose: Supportive Care
  • Breast Cancer
  • Lymphedema
  • Perioperative/Postoperative Complications
Procedure: management of therapy complications
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00005600
CDR0000067713, RMNHS-1489, EU-20004
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Royal Marsden NHS Foundation Trust
Not Provided
Study Chair: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) Royal Marsden NHS Foundation Trust
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP