Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Copenhagen University Hospital at Herlev.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01380912
First received: June 23, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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 Intervention
Breast Cancer
Drug: methylprednisoloneacetate

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • number of punctures [ Time Frame: 1 month after surgery ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

seroma will be analysed for concentration of cytokines, and eventual growth of bacteria


Estimated Enrollment: 160
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380912

Contacts
Contact: Charlotte Lanng, MD +4544884000 ext 89265 chalan01@heh.regionh.dk

Locations
Denmark
Chemistry Laboratorium, Copenhagen University Hospital at Gentofte Recruiting
Hellerup, Denmark, DK 2900
Contact: Pal B Szecsi, MD         
Department of Breast Surgery, Copenhagen University Hospital at Herlev Recruiting
Herlev, Denmark, 2730
Sub-Investigator: Christen K Axelsson         
Sub-Investigator: Birgitte Wegeberg, Nurse         
Sub-Investigator: Minea Mortensen, Nurse         
Sub-Investigator: Mette Okholm, MD         
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Gro M Qvamme, MD
  More Information

No publications provided

Responsible Party: Charlotte Lanng, MD, Department of Breast Surgery ,Herlev Hospital
ClinicalTrials.gov Identifier: NCT01380912     History of Changes
Other Study ID Numbers: H-4-2009-137
Study First Received: June 23, 2011
Last Updated: June 23, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
breast cancer
mastectomy
methylprednisoloneacetate
seroma
numbers of punctures

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014