Breast CancerNCT00005600
Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
A study testing management of therapy complications in people with Breast Cancer and Lymphedema, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Lymphedema, Perioperative/Postoperative Complications
- What is being tested?
- management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 1997to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Marsden NHS Foundation Trust - London
London, England, SW3 6JJ
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT
About this study
Official title: Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study
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.
Read the 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.
- Being tested
- management of therapy complications
- Keywords
- stage I breast cancer, stage II breast cancer, lymphedema, perioperative/postoperative complications
- Medical subject headings
- Breast Neoplasms, Lymphedema, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng), Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005600
- Sponsor's protocol ID
- CDR0000067713
- Other IDs
- RMNHS-1489, EU-20004
- Status last verified
- Dec 2005
- First submitted
- 2 May 2000
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00005600
- Acronym / sponsor ID
- CDR0000067713
- Keywords
- stage I breast cancer, stage II breast cancer, lymphedema, perioperative/postoperative complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 1997
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) study chair
Royal Marsden NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing management of therapy complications in people with Breast Cancer and Lymphedema, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.