Overview

This trial is active, not recruiting.

Conditions breast cancer, lymphedema, perioperative/postoperative complications
Treatment management of therapy complications
Sponsor Royal Marsden NHS Foundation Trust
Start date November 1997
Trial identifier NCT00005600, CDR0000067713, EU-20004, RMNHS-1489

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose supportive care

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).