RATIONALE: The use of axillary drains may help to prevent complications following axillary lymph node dissection.

PURPOSE: Randomized clinical trial to compare the effectiveness of three methods of axillary drainage following lymph node dissection in women who have stage I or stage II breast cancer.

Condition	Treatment or Intervention
stage I breast cancer stage II breast cancer Lymphedema perioperative/postoperative complications	Procedure: complications of therapy assessment/management  Procedure: supportive care/therapy

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

United Kingdom, England
      Royal Marsden Hospital - Sutton, Sutton,  England,  SM2 5PT,  United Kingdom; Recruiting
      Royal Marsden NHS Trust - London, London,  England,  SW3 6JJ,  United Kingdom; Recruiting

Study chairs or principal investigators

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng),  Study Chair,  Royal Marsden NHS Trust   

Study ID Numbers:  CDR0000067713; RMNHS-1489; EU-20004
Record last reviewed:  September 2000
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005600
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-05