Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer

June 23, 2011 updated by: Copenhagen University Hospital at Herlev

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?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Hellerup, Denmark, DK 2900
        • Recruiting
        • Chemistry Laboratorium, Copenhagen University Hospital at Gentofte
        • Contact:
          • Pal B Szecsi, MD
      • Herlev, Denmark, 2730
        • Recruiting
        • Department of Breast Surgery, Copenhagen University Hospital at Herlev
        • Sub-Investigator:
          • Christen K Axelsson
        • Sub-Investigator:
          • Birgitte Wegeberg, Nurse
        • Sub-Investigator:
          • Minea Mortensen, Nurse
        • Sub-Investigator:
          • Mette Okholm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients operated for primary breast cancer with mastectomy and eihter axillary dissection or Sentinel Node operation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of punctures
Time Frame: 1 month after surgery
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Gro M Qvamme, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2011

Study Completion (ANTICIPATED)

August 1, 2012

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2009-137

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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