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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.
First Received: May 2, 2000   Last Updated: May 9, 2009   History of Changes
Sponsor: 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
Lymphedema
Perioperative/Postoperative Complications
 Procedure: management of therapy complications

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome
MedlinePlus related topics: Breast Cancer Cancer Lymphedema
U.S. FDA Resources

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000067713, RMNHS-1489, EU-20004
Study First Received: May 2, 2000
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00005600     History of Changes
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:
Lymphedema
Lymphatic Diseases
Neoplasms
Pathologic Processes
Neoplasms by Site
 Skin Diseases
Postoperative Complications
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009



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