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: November 5, 2013
Last verified: December 2005
  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
Lymphedema
Perioperative/Postoperative Complications
Procedure: management of therapy complications

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
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 NHS Foundation Trust
Investigators
Study Chair: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005600     History of Changes
Other Study ID Numbers: CDR0000067713, RMNHS-1489, EU-20004
Study First Received: May 2, 2000
Last Updated: November 5, 2013
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

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Postoperative Complications
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014