Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer

Breast Cancer Clinical Trial

Official title:

Can Injection of Methylprednisoloneacetate 80 mg, in the Cavity After Mastectomy for Primary Breast Cancer, at the Time of Removal of the Drain, Prevent Seroma Formation?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01380912
• Other study ID #: H-4-2009-137
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2011
• Last updated: June 23, 2011
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: June 2011
• Source: Copenhagen University Hospital at Herlev
• Contact: Charlotte Lanng, MD
• Phone: +4544884000
• Email: chalan01[@]heh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

A randomised double-blinded study, in which the patients either get methylprednisoloneacetate or saline solution in the mastectomy cavity to evaluate the efficacy of methylprednisoloneacetate in preventing seroma in patients operated for primary breast cancer.

Description:

After mastectomy, up to 90 % of patients develops seroma in the cavity. The treatment is puncture, which is a small operation, but many patients have to come several times, and there is a risk of infection. In some cases further treatment can be postponed.

Preventing seroma to develop would be an improvement in the treatment of breast cancer patients operated with mastectomy.

An earlier study found that the seroma production was significant lower in the group who had Prednison injected directly into the cavity.

In this study the patient are divided into two groups: patients who have mastectomy and axillary dissection and patients who have mastectomy and Sentinel Node operation. Each group are examined separately.

Using Prednison in patients after operation could be a potential risk, but correct injection into the cavity will seldom give systemic side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• women with primary breast cancer or Ductal carcinoma in situ, mastectomy plus either Sentinel Node or Axillary dissection, signed consent form

Exclusion Criteria:

• dissection of the axilla in les than 4 month, treatment with steroids, pregnancy, if the patient don't speak danish, allergy towards steroid, other medical conditions which the investigator find contradict participating

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• methylprednisoloneacetate
Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.

Locations

Country	Name	City	State
Denmark	Chemistry Laboratorium, Copenhagen University Hospital at Gentofte	Hellerup
Denmark	Department of Breast Surgery, Copenhagen University Hospital at Herlev	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of punctures		1 month after surgery	Yes