Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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?

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: methylprednisoloneacetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| breast cancer<br>Patients operated with mastectomy and axillary dissection, who are randomised to injection of methylprednisoloneacetate in the cavity Patients operated with mastectomy and axillary dissection, who are randomised to injection of saline solution in the cavity Patients operated with mastectomy and Sentinel Node Operation, who are randomised to injection of methylprednisoloneacetate in the cavity Patients operated with mastectomy and Sentinel Node Operation, who are randomised to injection of saline solution in the cavity | Drug: methylprednisoloneacetate<br>* Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of punctures |  | 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, mastectomy, methylprednisoloneacetate, seroma, numbers of punctures