Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Unknown status

CT.gov ID

NCT01380912

Collaborator

University Hospital, Gentofte, Copenhagen (Other)

160

Enrollment

Locations

Duration (Months)

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: methylprednisoloneacetate

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 Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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?

Study Start Date :

Aug 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
breast cancer 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 Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.

Arm

Intervention/Treatment

breast cancer

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

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

Outcome Measures

Primary Outcome Measures

number of punctures [1 month after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chemistry Laboratorium, Copenhagen University Hospital at Gentofte	Hellerup		Denmark	DK 2900
2	Department of Breast Surgery, Copenhagen University Hospital at Herlev	Herlev		Denmark	2730