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Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

Primary Purpose

Breast Neoplasms, Mastectomy

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Solu-medrol 125 mg
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Mastectomy, Seroma, Breast cancer, Glucocorticoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women with primary breast cancer, planned for a mastectomy with and axillary dissection. Age over 18 years signed informed consent. Exclusion Criteria: 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 Uræmia Diabetes Other medical conditions, evaluated by the investigator, that make tke patient unfit for participation previous psychosis

Sites / Locations

  • Herlev Hospital, breast surgeryRecruiting

Outcomes

Primary Outcome Measures

seroma formation

Secondary Outcome Measures

Full Information

First Posted
March 27, 2006
Last Updated
September 5, 2007
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00307606
Brief Title
Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma
Official Title
Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Mastectomy
Keywords
Mastectomy, Seroma, Breast cancer, Glucocorticoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Solu-medrol 125 mg
Primary Outcome Measure Information:
Title
seroma formation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with primary breast cancer, planned for a mastectomy with and axillary dissection. Age over 18 years signed informed consent. Exclusion Criteria: 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 Uræmia Diabetes Other medical conditions, evaluated by the investigator, that make tke patient unfit for participation previous psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christen Axelsson
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital, breast surgery
City
Herlev
State/Province
Copenhagen
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Okholm
Phone
+4544884488
Ext
87406
Email
meok@herlevhosp.kbhamt.dk
First Name & Middle Initial & Last Name & Degree
mette Okholm

12. IPD Sharing Statement

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Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

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