Breast CancerPhase 2/3NCT01267552
Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer
A Phase 2/3 study testing Non drains will be placed during operation and Closed suction drainage in people with Breast Cancer and Complications, run by Universidade Federal de Goias at 2 sites in Brazil.
Trial summary
To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Complications, Seroma
- What is being tested?
- Non drains will be placed during operation and Closed suction drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2000to Dec 2007
- Phase
- Phase 2/3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage I and II breast cancer patients
- Will be submitted to breast conserving therapy, with full axillary lymphadenectomy
Who cannot join
- diabetes
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Goiânia, Goiás, 74605070
Mastology Program of Federal University of Goias
Goiânia, Goiás, 74605070
About this study
Official title: Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment
To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.
Read the detailed description
The primary objective is to study the safety of not draining the axilla, considering the total number of patients without complication among breast cancer patients treated by means of conservative surgery and full axillary lymphadenectomy, with or without axillary drainage.
The secondary objectives will be the numbers of aspiration punctures, volumes of fluid aspirated and the total volumes of fluid produced.
- Conditions
- Breast Cancer, Complications, Seroma
- Being tested
- Non drains will be placed during operation, Closed suction drainage
- Keywords
- Breast cancer, Surgery, Complications, Drainage, Seroma
- Medical subject headings
- Breast Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non drains will be placed during operationProcedure or surgery
Also called No drainage
Non drains will be placed during operation
Closed suction drainageProcedure or surgery
Closed suction drainage will be placed during operation
| Study group | Role | What they receive |
|---|---|---|
| Non drainage arm | Experimental | No drains will be placed during operation Receives: Procedure: Non drains will be placed during operation |
| Drainage arm | Active comparator | Closed suction drains will be placed during operation Receives: Procedure: Closed suction drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The safety of not draining the axilla, will be considered by the total number of patients without complication among breast cancer patients treated by means of breast conserving surgery and full axillary lymphadenectomy
Measured: 6 months
Secondary outcomes (1)
Serous fluid
The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startJul 2000
- Primary completionSep 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- Araujo Jorge Hospital
- Investigators
- Ruffo Freitas-Junior, PhD, Principal investigator, Universidade Federal de GoiasLuiz Fernando J Ribeiro, PhD, Study chair, Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267552
- Sponsor's protocol ID
- Drains Trial
- Other IDs
- Drains trial01/2007
- Status last verified
- Jul 2010
- First submitted
- 27 Dec 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Freitas-Junior R, Ribeiro LFJ, Moreira MAR, Queiroz GS, Esperidiao MD, Silva MAC, Pereira RJ, Zampronha RAC, Rahal RMS, Soares LR, Dos Santos DL, Thomazini MV, de Faria CFS, Paulinelli RR. Complete axillary dissection without drainage for the surgical treatment of breast cancer: a randomized clinical trial. Clinics (Sao Paulo). 2017 Jul;72(7):426-431. doi: 10.6061/clinics/2017(07)07.
PubMed 28793003
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT01267552
- Acronym / sponsor ID
- Drains Trial
- Conditions
- Breast Cancer, Complications, Seroma
- Keywords
- Breast cancer, Surgery, Complications, Drainage, Seroma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Araujo Jorge Hospital
- Study start
- Jul 2000
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Dec 2010 (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.
To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.
Detailed description
The primary objective is to study the safety of not draining the axilla, considering the total number of patients without complication among breast cancer patients treated by means of conservative surgery and full axillary lymphadenectomy, with or without axillary drainage.
The secondary objectives will be the numbers of aspiration punctures, volumes of fluid aspirated and the total volumes of fluid produced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non drainage arm | Experimental | Procedure: Non drains will be placed during operationNo drains will be placed during operation |
| Drainage arm | Active comparator | Procedure: Closed suction drainageClosed suction drains will be placed during operation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Stage I and II breast cancer patients
- Will be submitted to breast conserving therapy, with full axillary lymphadenectomy
Key exclusion criteria (1 listed)
- diabetes
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 |
|---|---|---|
| Non drains will be placed during operationAlso: No drainageNon drains will be placed during operation | Procedure or surgery | Non drainage arm |
| Closed suction drainageClosed suction drainage will be placed during operation | Procedure or surgery | Drainage arm |
Primary outcome
Safety
Time frame: 6 months
The safety of not draining the axilla, will be considered by the total number of patients without complication among breast cancer patients treated by means of breast conserving surgery and full axillary lymphadenectomy
1 secondary outcome
Serous fluid
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
- Derived from this study: PubMed 28793003Freitas-Junior R, Ribeiro LFJ, Moreira MAR, Queiroz GS, Esperidiao MD, Silva MAC, Pereira RJ, Zampronha RAC, Rahal RMS, Soares LR, Dos Santos DL, Thomazini MV, de Faria CFS, Paulinelli RR. Complete axillary dissection without drainage for the surgical treatment of breast cancer: a randomized clinical trial. Clinics (Sao Paulo). 2017 Jul;72(7):426-431. doi: 10.6061/clinics/2017(07)07.
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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.
Ruffo Freitas-Junior, PhD principal investigator
Universidade Federal de Goias
Luiz Fernando J Ribeiro, PhD study chair
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Non drains will be placed during operation and Closed suction drainage in people with Breast Cancer and Complications, run by Universidade Federal de Goias at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Dec 2010. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Safety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01267552, which also lists 1 linked publication.
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 28 Dec 2010.