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

Tracking Information

First Received Date ^ICMJE

May 2, 2000

Last Updated Date

May 9, 2009

Start Date ^ICMJE

November 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00005600 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Active Control

Condition ^ICMJE

Breast Cancer
Lymphedema
Perioperative/Postoperative Complications

Intervention ^ICMJE

Procedure: management of therapy complications

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00005600

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067713, RMNHS-1489, EU-20004

Study Sponsor ^ICMJE

Royal Marsden - London

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)

Royal Marsden - London

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2005

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