Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

Breast Neoplasms Clinical Trial

Official title:

Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00307606
• Other study ID #: seromprotocol
• Status: Recruiting
• Phase: Phase 4
• First received: March 27, 2006
• Last updated: September 5, 2007
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: December 2005
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Mastectomy

Intervention

Drug:
• Solu-medrol 125 mg

Locations

Country	Name	City	State
Denmark	Herlev Hospital, breast surgery	Herlev	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroma formation