NCT00005600

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

November 6, 2013

Status Verified

December 1, 2005

First QC Date

May 2, 2000

Last Update Submit

November 5, 2013

Conditions

Breast CancerLymphedemaPerioperative/Postoperative Complications

Keywords

stage I breast cancerstage II breast cancerlymphedemaperioperative/postoperative complications

Interventions

management of therapy complicationsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Royal Marsden NHS Foundation Trust - London

London, England, SW3 6JJ, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphedemaPostoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

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

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

November 1, 1997

Last Updated

November 6, 2013

Record last verified: 2005-12

Locations

GB(2)