Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer

• Conditions: Breast Cancer
• Interventions: Drug: methylprednisoloneacetate

• Registration Number: NCT01380912
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-08
• Status Verified: 2011-06
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-23
• Last Update Submitted: 2011-06-23
• Study First Posted: 2011-06-27
• Last Update Posted: 2011-06-27
• Primary Completion: 2011-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
breast cancer	methylprednisoloneacetate	1. Patients operated with mastectomy and axillary dissection, who are randomised to injection of methylprednisoloneacetate in the cavity 2. Patients operated with mastectomy and axillary dissection, who are randomised to injection of saline solution in the cavity 3. Patients operated with mastectomy and Sentinel Node Operation, who are randomised to injection of methylprednisoloneacetate in the cavity 4. Patients operated with mastectomy and Sentinel Node Operation, who are randomised to injection of saline solution in the cavity

Primary Outcome Measures

Name	Time	Method
number of punctures	1 month after surgery

Trial Locations

Locations (2)

Chemistry Laboratorium, Copenhagen University Hospital at Gentofte; 🇩🇰 Hellerup, Denmark

Department of Breast Surgery, Copenhagen University Hospital at Herlev; 🇩🇰 Herlev, Denmark