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

NCT ID: NCT00005600

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1997-11-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Lymphedema Perioperative/Postoperative Complications

Keywords

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stage I breast cancer stage II breast cancer lymphedema perioperative/postoperative complications

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Interventions

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management of therapy complications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

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

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS Foundation Trust - London

London, England, United Kingdom

Site Status

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RMNHS-1489

Identifier Type: -

Identifier Source: secondary_id

EU-20004

Identifier Type: -

Identifier Source: secondary_id

CDR0000067713

Identifier Type: -

Identifier Source: org_study_id