Breast CancerCHLONKANCT01221064
Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance
A study testing Early drainage removal and Late drainage removal in people with Breast Cancer, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Early drainage removal and Late drainage removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2010to May 2014
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IIA and IIB breast cancer treated with radical mastectomy
- Obtaining informed consent
- Total amount of lymph in postoperative day 1 <150ml
Who cannot join
- Stage I, III-IV breast cancer
- History of benign breast neoplasm or malignant disease of any origin
- Any breast surgery in the past
- Weight <50kg
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdansk, Department of Surgical Oncology
Gdansk, Pomeranian Voivodeship, 80-952
Jacek Zielinsk, MD, PhD, 660 123 402 ext. +48, jaziel@gumed.edu.pl
Pawel Kabata, MD, 509 707 959 ext. +48, pakabata@uck.gda.pl
About this study
Official title: Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance
The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea
Read the detailed description
Patients with early drainage removal will be compared with patients in whom drainage will be kept until daily lymphorrhoea is 30ml
- Conditions
- Breast Cancer
- Being tested
- Early drainage removal, Late drainage removal
- Keywords
- Breast cancer, Axillary clearance, lymphorrhoea
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early drainage removalProcedure or surgery
Drainage will be removed in postoperative day 1
Late drainage removalProcedure or surgery
Drains will be kept until daily drainage is 30ml and then removed
| Study group | Role | What they receive |
|---|---|---|
| Early drainage removal | Other | Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis Receives: Procedure: Early drainage removal |
| Late drainage removal | Other | Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed Receives: Procedure: Late drainage removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total lymph volume and time
Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery
Measured: 3 months
Secondary outcomes (1)
Post operative pain assessment
Post operative pain assessment using VAS (Visual Analogue Scale) scale until 30 days after surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2013 (estimated)
- Study completionMay 2014 (estimated)
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 Medical University of GdanskThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Zielinski, Medical University of Gdansk
- Investigators
- Janusz Jaśkiewicz, MD, PhD, Study director, Medical University of GdanskJacek Zielinski, MD, PhD, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221064
- Sponsor's protocol ID
- MUGSO-001
- Acronym
- CHLONKA
- Status last verified
- Jan 2012
- First submitted
- 6 Oct 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance
- ClinicalTrials.gov ID
- NCT01221064
- Acronym / sponsor ID
- CHLONKA / MUGSO-001
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Axillary clearance, lymphorrhoea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 14 Oct 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.
The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea
Detailed description
Patients with early drainage removal will be compared with patients in whom drainage will be kept until daily lymphorrhoea is 30ml
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early drainage removal | Other | Procedure: Early drainage removalPatients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis |
| Late drainage removal | Other | Procedure: Late drainage removalPatients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage IIA and IIB breast cancer treated with radical mastectomy
- Obtaining informed consent
- Total amount of lymph in postoperative day 1 <150ml
Key exclusion criteria (4 listed)
- Stage I, III-IV breast cancer
- History of benign breast neoplasm or malignant disease of any origin
- Any breast surgery in the past
- Weight <50kg
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 |
|---|---|---|
| Early drainage removalDrainage will be removed in postoperative day 1 | Procedure or surgery | Early drainage removal |
| Late drainage removalDrains will be kept until daily drainage is 30ml and then removed | Procedure or surgery | Late drainage removal |
Primary outcome
Total lymph volume and time
Time frame: 3 months
Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery
1 secondary outcome
Post operative pain assessment
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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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.
Janusz Jaśkiewicz, MD, PhD study director
Medical University of Gdansk
Jacek Zielinski, MD, PhD principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early drainage removal and Late drainage removal in people with Breast Cancer, run by Medical University of Gdansk at 1 site in Poland.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Contact Jacek Zielinski, MD, PhD (660 123 402 ext. +48, jaziel@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total lymph volume and time (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 31 Jan 2012.