Breast NeoplasmsPhase 4NCT00307606
Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma
A Phase 4 study testing Solu-medrol 125 mg in people with Breast Neoplasms and Mastectomy, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Background Seroma formation is a common problem after mastectomy. The incidence various between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and repeated skin puncture is necessary to remove the seroma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Mastectomy
- What is being tested?
- Solu-medrol 125 mg
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2005to Dec 2007
- 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
- Women with primary breast cancer, planned for a mastectomy with and axillary dissection.
- Age over 18 years
- signed informed consent.
Who cannot join
- Men
- Treatment with glucocorticoids within the last month before surgery, including inhalation products
- Pregnant.
- Not able to speak danish
- Severe heart disease
- Treatment with carbamazepine, phenytoin, phenobarbital, rifampicin, salicylates and ciclosporin
Show all 10Show fewer
- Uræmia
- Diabetes
- Other medical conditions, evaluated by the investigator, that make tke patient unfit for participation
- previous psychosis
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev Hospital, breast surgery
Herlev, Copenhagen, 2730
Mette Okholm, +4544884488 ext. 87406, meok@herlevhosp.kbhamt.dk
mette Okholm
About this study
Background Seroma formation is a common problem after mastectomy. The incidence various between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory visits this also leads to an increased risk of infection, and the adjuvant treatment can be delayed for several weeks
Different procedures have been tried to avoid seroma formation. Among these are for ex. : immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing of the dead space of the cavity, different chemical substances as thrombin, tranexamacid and fibrin. Non of these results has been successful.
Read more
Seroma formation is most likely the result of the inflammatory response due to wound healing. In the seroma fluid several factors have been detected that support this assumption. These factors are: high levels of IgG, leucocytes, granulocytes, proteinases, proteinases inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6 og IL-1).
On the basis of this, an inhibition of the inflammatory response might result in a decrease of seroma formation, and perhaps improve quality of life after mastectomy.
Steroids inhibit the inflammatory response for example by inhibition of the cytokine function. It has been shown that a high single dose of steroid infusion (30mg/kg solu-medrol) inhibits the normal IL 6 response after colon resection. Newer studies have shown that even at a lower dose the inflammatory response is inhibited. In several studies of head and neck surgery the oedema in surgical area is reduced after a single dose of 125 mg solumedrol. It is precisely this effect of reduced fluid formation we want to obtain in our study. We have therefore chosen to use a single dose of 125 mg of solumedrol in this study. Even at the largest single dose of glucocorticoids there have not been seen any increasing in surgical complications.
The aim of the study: To find out whether single dose of glucocorticoid can reduce the seroma formation after mastectomy
Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given 1,5 hours before surgery in 20 patients, and the other 20 patients are the control group
Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either sentinel node biopsy or complete axillary dissection.
Read the detailed description
Background Seroma formation is a common problem after mastectomy. The incidence various between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory visits this also leads to an increased risk of infection, and the adjuvant treatment can be delayed for several weeks
Different procedures have been tried to avoid seroma formation. Among these are for ex. : immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing of the dead space of the cavity, different chemical substances as thrombin, tranexamacid and fibrin. Non of these results has been successful.
Seroma formation is most likely the result of the inflammatory response due to wound healing. In the seroma fluid several factors have been detected that support this assumption. These factors are: high levels of IgG, leucocytes, granulocytes, proteinases, proteinases inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6 og IL-1).
On the basis of this, an inhibition of the inflammatory response might result in a decrease of seroma formation, and perhaps improve quality of life after mastectomy.
Steroids inhibit the inflammatory response for example by inhibition of the cytokine function. It has been shown that a high single dose of steroid infusion (30mg/kg solu-medrol) inhibits the normal IL 6 response after colon resection. Newer studies have shown that even at a lower dose the inflammatory response is inhibited. In several studies of head and neck surgery the oedema in surgical area is reduced after a single dose of 125 mg solumedrol. It is precisely this effect of reduced fluid formation we want to obtain in our study. We have therefore chosen to use a single dose of 125 mg of solumedrol in this study. Even at the largest single dose of glucocorticoids there have not been seen any increasing in surgical complications.
The aim of the study: To find out whether single dose of glucocorticoid can reduce the seroma formation after mastectomy
Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given 1,5 hours before surgery in 20 patients, and the other 20 patients are the control group
Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either sentinel node biopsy or complete axillary dissection.
- Conditions
- Breast Neoplasms, Mastectomy
- Being tested
- Solu-medrol 125 mg
- Keywords
- Mastectomy, Seroma, Breast cancer, Glucocorticoid
- 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.
Solu-medrol 125 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
seroma formation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startDec 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Christen Axelsson, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307606
- Sponsor's protocol ID
- seromprotocol
- Status last verified
- Dec 2005
- First submitted
- 27 Mar 2006
- Last updated
- 6 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burak WE Jr, Goodman PS, Young DC, Farrar WB. Seroma formation following axillary dissection for breast cancer: risk factors and lack of influence of bovine thrombin. J Surg Oncol. 1997 Jan;64(1):27-31. doi: 10.1002/(sici)1096-9098(199701)64:13.0.co;2-r.
PubMed 9040797Watt-Boolsen S, Jacobsen K, Blichert-Toft M. Total mastectomy with special reference to surgical technique, extent of axillary dissection and complications. Acta Oncol. 1988;27(6A):663-5. doi: 10.3109/02841868809091765.
PubMed 3219219Jeffrey SS, Goodson WH 3rd, Ikeda DM, Birdwell RL, Bogetz MS. Axillary lymphadenectomy for breast cancer without axillary drainage. Arch Surg. 1995 Aug;130(8):909-12; discussion 912-3. doi: 10.1001/archsurg.1995.01430080111018.
PubMed 7632155Kumar S, Lal B, Misra MC. Post-mastectomy seroma: a new look into the aetiology of an old problem. J R Coll Surg Edinb. 1995 Oct;40(5):292-4.
PubMed 8523301Porter KA, O'Connor S, Rimm E, Lopez M. Electrocautery as a factor in seroma formation following mastectomy. Am J Surg. 1998 Jul;176(1):8-11. doi: 10.1016/s0002-9610(98)00093-2.
PubMed 9683123Schultz I, Barholm M, Grondal S. Delayed shoulder exercises in reducing seroma frequency after modified radical mastectomy: a prospective randomized study. Ann Surg Oncol. 1997 Jun;4(4):293-7. doi: 10.1007/BF02303577.
PubMed 9181227Browse DJ, Goble D, Jones PA. Axillary node clearance: who wants to immobilize the shoulder? Eur J Surg Oncol. 1996 Dec;22(6):569-70. doi: 10.1016/s0748-7983(96)92164-2.
PubMed 9005140Barwell J, Campbell L, Watkins RM, Teasdale C. How long should suction drains stay in after breast surgery with axillary dissection? Ann R Coll Surg Engl. 1997 Nov;79(6):435-7.
PubMed 9422871Liu CD, McFadden DW. Overnight closed suction drainage after axillary lymphadenectomy for breast cancer. Am Surg. 1997 Oct;63(10):868-70.
PubMed 9322660Bonnema J, van Geel AN, Ligtenstein DA, Schmitz PI, Wiggers T. A prospective randomized trial of high versus low vacuum drainage after axillary dissection for breast cancer. Am J Surg. 1997 Feb;173(2):76-9. doi: 10.1016/S0002-9610(96)00416-3.
PubMed 9074367Medwid A. A new and quick method for treating postmastectomy seromas. Surg Gynecol Obstet. 1992 Feb;174(2):161-2.
PubMed 1734578Tadych K, Donegan WL. Postmastectomy seromas and wound drainage. Surg Gynecol Obstet. 1987 Dec;165(6):483-7.
PubMed 3686312Holcombe C, West N, Mansel RE, Horgan K. The satisfaction and savings of early discharge with drain in situ following axillary lymphadenectomy in the treatment of breast cancer. Eur J Surg Oncol. 1995 Dec;21(6):604-6. doi: 10.1016/s0748-7983(95)95133-4.
PubMed 8631403Coveney EC, O'Dwyer PJ, Geraghty JG, O'Higgins NJ. Effect of closing dead space on seroma formation after mastectomy--a prospective randomized clinical trial. Eur J Surg Oncol. 1993 Apr;19(2):143-6.
PubMed 8491318O'Dwyer PJ, O'Higgins NJ, James AG. Effect of closing dead space on incidence of seroma after mastectomy. Surg Gynecol Obstet. 1991 Jan;172(1):55-6.
PubMed 1985342
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma
- ClinicalTrials.gov ID
- NCT00307606
- Acronym / sponsor ID
- seromprotocol
- Conditions
- Breast Neoplasms, Mastectomy
- Keywords
- Mastectomy, Seroma, Breast cancer, Glucocorticoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Dec 2007
- First posted
- 28 Mar 2006 (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.
Background Seroma formation is a common problem after mastectomy. The incidence various between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory visits this also leads to an increased risk of infection, and the adjuvant treatment can be delayed for several weeks
Different procedures have been tried to avoid seroma formation. Among these are for ex. : immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing of the dead space of the cavity, different chemical substances as thrombin, tranexamacid and fibrin. Non of these results has been successful.
Seroma formation is most likely the result of the inflammatory response due to wound healing. In the seroma fluid several factors have been detected that support this assumption. These factors are: high levels of IgG, leucocytes, granulocytes, proteinases, proteinases inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6 og IL-1).
On the basis of this, an inhibition of the inflammatory response might result in a decrease of seroma formation, and perhaps improve quality of life after mastectomy.
Steroids inhibit the inflammatory response for example by inhibition of the cytokine function. It has been shown that a high single dose of steroid infusion (30mg/kg solu-medrol) inhibits the normal IL 6 response after colon resection. Newer studies have shown that even at a lower dose the inflammatory response is inhibited. In several studies of head and neck surgery the oedema in surgical area is reduced after a single dose of 125 mg solumedrol. It is precisely this effect of reduced fluid formation we want to obtain in our study. We have therefore chosen to use a single dose of 125 mg of solumedrol in this study. Even at the largest single dose of glucocorticoids there have not been seen any increasing in surgical complications.
The aim of the study: To find out whether single dose of glucocorticoid can reduce the seroma formation after mastectomy
Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given 1,5 hours before surgery in 20 patients, and the other 20 patients are the control group
Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either sentinel node biopsy or complete axillary dissection.
Detailed description
Background Seroma formation is a common problem after mastectomy. The incidence various between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory visits this also leads to an increased risk of infection, and the adjuvant treatment can be delayed for several weeks
Different procedures have been tried to avoid seroma formation. Among these are for ex. : immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing of the dead space of the cavity, different chemical substances as thrombin, tranexamacid and fibrin. Non of these results has been successful.
Seroma formation is most likely the result of the inflammatory response due to wound healing. In the seroma fluid several factors have been detected that support this assumption. These factors are: high levels of IgG, leucocytes, granulocytes, proteinases, proteinases inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6 og IL-1).
On the basis of this, an inhibition of the inflammatory response might result in a decrease of seroma formation, and perhaps improve quality of life after mastectomy.
Steroids inhibit the inflammatory response for example by inhibition of the cytokine function. It has been shown that a high single dose of steroid infusion (30mg/kg solu-medrol) inhibits the normal IL 6 response after colon resection. Newer studies have shown that even at a lower dose the inflammatory response is inhibited. In several studies of head and neck surgery the oedema in surgical area is reduced after a single dose of 125 mg solumedrol. It is precisely this effect of reduced fluid formation we want to obtain in our study. We have therefore chosen to use a single dose of 125 mg of solumedrol in this study. Even at the largest single dose of glucocorticoids there have not been seen any increasing in surgical complications.
The aim of the study: To find out whether single dose of glucocorticoid can reduce the seroma formation after mastectomy
Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given 1,5 hours before surgery in 20 patients, and the other 20 patients are the control group
Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either sentinel node biopsy or complete axillary dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with primary breast cancer, planned for a mastectomy with and axillary dissection.
- Age over 18 years
- signed informed consent.
Key exclusion criteria (10 listed)
- Men
- Treatment with glucocorticoids within the last month before surgery, including inhalation products
- Pregnant.
- Not able to speak danish
- Severe heart disease
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 |
|---|---|---|
| Solu-medrol 125 mg | Drug | – |
Primary outcome
seroma formation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2007.
- Background: PubMed 9040797Burak WE Jr, Goodman PS, Young DC, Farrar WB. Seroma formation following axillary dissection for breast cancer: risk factors and lack of influence of bovine thrombin. J Surg Oncol. 1997 Jan;64(1):27-31. doi: 10.1002/(sici)1096-9098(199701)64:13.0.co;2-r.
- Background: PubMed 3219219Watt-Boolsen S, Jacobsen K, Blichert-Toft M. Total mastectomy with special reference to surgical technique, extent of axillary dissection and complications. Acta Oncol. 1988;27(6A):663-5. doi: 10.3109/02841868809091765.
- Background: PubMed 7632155Jeffrey SS, Goodson WH 3rd, Ikeda DM, Birdwell RL, Bogetz MS. Axillary lymphadenectomy for breast cancer without axillary drainage. Arch Surg. 1995 Aug;130(8):909-12; discussion 912-3. doi: 10.1001/archsurg.1995.01430080111018.
- Background: PubMed 8523301Kumar S, Lal B, Misra MC. Post-mastectomy seroma: a new look into the aetiology of an old problem. J R Coll Surg Edinb. 1995 Oct;40(5):292-4.
- Background: PubMed 9683123Porter KA, O'Connor S, Rimm E, Lopez M. Electrocautery as a factor in seroma formation following mastectomy. Am J Surg. 1998 Jul;176(1):8-11. doi: 10.1016/s0002-9610(98)00093-2.
- Background: PubMed 9181227Schultz I, Barholm M, Grondal S. Delayed shoulder exercises in reducing seroma frequency after modified radical mastectomy: a prospective randomized study. Ann Surg Oncol. 1997 Jun;4(4):293-7. doi: 10.1007/BF02303577.
- Background: PubMed 9005140Browse DJ, Goble D, Jones PA. Axillary node clearance: who wants to immobilize the shoulder? Eur J Surg Oncol. 1996 Dec;22(6):569-70. doi: 10.1016/s0748-7983(96)92164-2.
- Background: PubMed 9422871Barwell J, Campbell L, Watkins RM, Teasdale C. How long should suction drains stay in after breast surgery with axillary dissection? Ann R Coll Surg Engl. 1997 Nov;79(6):435-7.
- Background: PubMed 9322660Liu CD, McFadden DW. Overnight closed suction drainage after axillary lymphadenectomy for breast cancer. Am Surg. 1997 Oct;63(10):868-70.
- Background: PubMed 9074367Bonnema J, van Geel AN, Ligtenstein DA, Schmitz PI, Wiggers T. A prospective randomized trial of high versus low vacuum drainage after axillary dissection for breast cancer. Am J Surg. 1997 Feb;173(2):76-9. doi: 10.1016/S0002-9610(96)00416-3.
- Background: PubMed 1734578Medwid A. A new and quick method for treating postmastectomy seromas. Surg Gynecol Obstet. 1992 Feb;174(2):161-2.
- Background: PubMed 3686312Tadych K, Donegan WL. Postmastectomy seromas and wound drainage. Surg Gynecol Obstet. 1987 Dec;165(6):483-7.
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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.
Christen Axelsson principal investigator
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 Solu-medrol 125 mg in people with Breast Neoplasms and Mastectomy, run by Herlev Hospital at 1 site in Denmark.
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 10 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 6 Sep 2007. 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 Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seroma formation. 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 NCT00307606, which also lists 34 linked publications.
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 Sep 2007.