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

Breast Cancer Clinical Trial

Official title:

Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005600
• Other study ID #: CDR0000067713
• Secondary ID: RMNHS-1489EU-200
• Status: Active, not recruiting
• Phase: N/A
• First received: May 2, 2000
• Last updated: November 5, 2013
• Start date: November 1997

Study information

• Verified date: December 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust - London	London	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,