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

Primary Purpose

Breast Cancer, Lymphedema, Perioperative/Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
management of therapy complications
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, lymphedema, perioperative/postoperative complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Marsden NHS Foundation Trust - London
  • Royal Marsden NHS Foundation Trust - Surrey

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
November 5, 2013
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00005600
Brief Title
Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
Official Title
Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema, Perioperative/Postoperative Complications
Keywords
stage I breast cancer, stage II breast cancer, lymphedema, perioperative/postoperative complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
management of therapy complications

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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

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