Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer - Full Text View

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

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:	February 6, 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

Study placed in the following topic categories:

Lymphedema
Skin Diseases
Postoperative Complications
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009