Breast CancerPhase 4NCT01216254
Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation
A Phase 4 study testing classic v high-frequency electrocoagulation in people with Breast Cancer, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The aim of this study is to assess the outcomes of breast conserving therapy operation depending on the type of surgical tool used: classic electrocoagulation with higher operative temperatures and high frequency electrocoagulation with lower operative temperatures. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- classic v high-frequency electrocoagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2010to Oct 2013
- Phase
- Phase 4
- 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
Who may be able to join
- female
- age 18-100
- breast cancer
- stage IIA and II B (cT1a-3; cN0-1; cM0)
- no previous breast surgery
- no previous cancer
- obtained informed consent
Who cannot join
- stages I, III, IV
- localised breast infection
- previous breast surgery for any cause
- previous cancer
- no voluntary consent
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Surgical Oncology
Gdansk, Pomeranian Voivodeship, 80-211
Jacek Zielinski, M.D., Ph.D.
Maciej Bobowicz, M.D.
About this study
Official title: Prospective, Randomized Clinical Trial Comparing Pain Sensation, Seroma Formation and Quality od Life Following BCT With SLND in Breast Cancer Patients Operated With Classic Versus High-frequency Electrocoagulation.
The aim of this study is to assess the outcomes of breast conserving therapy operation depending on the type of surgical tool used: classic electrocoagulation with higher operative temperatures and high frequency electrocoagulation with lower operative temperatures. The investigators would assess the pain levels, length and amount of the lymphatic secretion as well as quality of life following breast conserving surgery.
- Conditions
- Breast Cancer
- Being tested
- classic v high-frequency electrocoagulation
- Keywords
- breast cancer, stage 2, breast conserving therapy, sentinel lymph node dissection, high frequency electrocoagulation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic v high-frequency electrocoagulationDevice
Also called Ellmann
During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.
| Study group | Role | What they receive |
|---|---|---|
| Classic electrocoagulation | Active comparator | Arm of the study where the classic low-frequency electrocoagulation is used during the operation Receives: Device: classic v high-frequency electrocoagulation |
| High Frequency electrocoagulation | Experimental | Arm of the study where the tested high-frequency electrocoagulation is used during the operation Receives: Device: classic v high-frequency electrocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Control
Pain assessment would be performed using Visual Analogue Scale (VAS) at the days 1-5, 10 (+/- 2), 20 (+/- 2), 30 (+/- 2), and 12 weeks (+/- 2 days). SF - MPQ questionnaire would be filled in on admission, 10th (+/- 2) post-operative day and 12 weeks (+/- 2 days)after surgery.
Measured: From the day before surgery up to 12 weeks (+/-2days) after surgery
Secondary outcomes (3)
Quality of life (QoL)
Pre-operative assessment of QoL would be performed by psychologist using questionnaires: CISS, HADS - M, Eysencka. Postoperative assessment of QoL would be performed using QLQ C30 and QLQ BR 23 questionnaires 12 weeks (+/- 2 days)after surgery
Measured: From the day before surgery up to 12 weeks (+/-2days) after surgery
Length of lymphatic secretion
Number of days of lymphatic secretion would be assessed.
Measured: From the day before surgery up to 12 weeks (+/-2days) after surgery
Amount of lymphatic secretion
Amount of lymphatic secretion would be measured until it stops on daily basis.
Measured: From the day before surgery up to 12 weeks (+/-2days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 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
- Jacek Zielinski, M.D., Ph.D., Principal investigator, Medical University of GdanskJanusz Jaskiewicz, M.D., Ph.D., Study director, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216254
- Sponsor's protocol ID
- NKEBN/219/2010
- Status last verified
- Jan 2012
- First submitted
- 4 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, Randomized Clinical Trial Comparing Pain Sensation, Seroma Formation and Quality od Life Following BCT With SLND in Breast Cancer Patients Operated With Classic Versus High-frequency Electrocoagulation.
- ClinicalTrials.gov ID
- NCT01216254
- Acronym / sponsor ID
- NKEBN/219/2010
- Conditions
- Breast Cancer
- Keywords
- breast cancer, stage 2, breast conserving therapy, sentinel lymph node dissection, high frequency electrocoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 7 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 this study is to assess the outcomes of breast conserving therapy operation depending on the type of surgical tool used: classic electrocoagulation with higher operative temperatures and high frequency electrocoagulation with lower operative temperatures. The investigators would assess the pain levels, length and amount of the lymphatic secretion as well as quality of life following breast conserving surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic electrocoagulation | Active comparator | Device: classic v high-frequency electrocoagulationArm of the study where the classic low-frequency electrocoagulation is used during the operation |
| High Frequency electrocoagulation | Experimental | Device: classic v high-frequency electrocoagulationArm of the study where the tested high-frequency electrocoagulation is used during the operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- female
- age 18-100
- breast cancer
- stage IIA and II B (cT1a-3; cN0-1; cM0)
- no previous breast surgery
Key exclusion criteria (5 listed)
- stages I, III, IV
- localised breast infection
- previous breast surgery for any cause
- previous cancer
- no voluntary consent
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 |
|---|---|---|
| classic v high-frequency electrocoagulationAlso: EllmannDuring the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary. | Device | Classic electrocoagulation, High Frequency electrocoagulation |
Primary outcome
Pain Control
Time frame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Pain assessment would be performed using Visual Analogue Scale (VAS) at the days 1-5, 10 (+/- 2), 20 (+/- 2), 30 (+/- 2), and 12 weeks (+/- 2 days). SF - MPQ questionnaire would be filled in on admission, 10th (+/- 2) post-operative day and 12 weeks (+/- 2 days)after surgery.
3 secondary outcomes
Quality of life (QoL)
Time frame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Length of lymphatic secretion
Time frame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Amount of lymphatic secretion
Time frame: From the day before surgery up to 12 weeks (+/-2days) after surgery
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.
Jacek Zielinski, M.D., Ph.D. principal investigator
Medical University of Gdansk
Janusz Jaskiewicz, M.D., Ph.D. study director
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 Phase 4 study testing classic v high-frequency electrocoagulation 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 7 inclusion and 5 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, M.D., Ph.D. (+48583492440, jaziel@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Control (time frame: From the day before surgery up to 12 weeks (+/-2days) after surgery). 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.