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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04596046
Other study ID # 95775
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2019
Est. completion date July 17, 2020

Study information

Verified date October 2020
Source Gaziosmanpasa Taksim Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Idiopathic granulomatous mastitis (IGM) is a rare, benign inflammatory breast disease that mimics malignancy owing to its features of appearance.In our research, we intended to compare the efficiency of local (intralesional) steroid administration with systemic (peroral) steroid. A total of 36 patients who had been histopathologically diagnosed with IGM and whose other factors had been microbiologically excluded were included in the study. The patients were randomized into two sub-groups that would be treated with systemic and local steroids. Of the patients, 19 were administered with 0.5-1 mg/kg/day peroral systemic steroid, and 17 were administered with 40-200 mg/ml intralesional local steroid regarding the severity of the lesion. All patients were evaluated through physical examination one week after the completion of the treatment. Subsequently, the follow-up of the patients was performed thorough physical examination and ultrasonography and/or magnetic resonance imaging at the 1st, 3rd, and 6th months.


Description:

The research was designed as a prospective randomized-controlled study.Prior to the study, approval was obtained from the local ethics committee of our hospital (reg.:162)The diagnosis of all patients was carried out through physical examination, imaging, and histopathology. Prior to the treatment, microbiological analysis was conducted concurrently with the biopsy.Patients who had contraindications with the use of steroids, those with active infections, as well as patients who were pregnant, and who had been diagnosed with breast cancer, were not included in the study. The patients were sub-divided into two groups as Group S (systemic-peroral steroid) and Group L (local-intralesional steroid) by using the sealed envelope randomization method. Group S: Medication of oral methylprednisolonewas administered to the patients following the adjustment based on the severity of the lesion and regarding the clinic. The prednisolone dose was 0.5 mg/kg/day in patients with painful, small (<5.0 cm) unilateral lesions whereas in multiple, bilateral lesions with the diameter of ≥5 cm or for those who had significant cutaneous ulceration, the prednisolone dose was specified as 1 mg/kg/day. Patients were informed about potential adverse effects. The medication was completed by reducing the dose. Patients in the systemic steroid group were advised to receive the medication after eating, to restrict salt and sugar consumption throughout the treatment, to quit smoking if they are using, and a proton pump inhibitor was started.Group L: Triamcinolone acetonidewas administered to the patients through injecting inside the lesion.The occurrence of systemic adverse effects in the course of the treatment was considered as the reason to discontinue the medication in all groups. Follow-up examinations of all patients at the 6th month were regarded as the endpoint of the treatment. As a consequence, it can be stated that the local (intralesional) steroid administration is also a treatment method, which is comparable to systemic steroid administration and had similar side effects. Nonetheless, it will be appropriate to promote this method by performing studies, which involve a larger population with more patients, and which is also long termed.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 17, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who were diagnosed with IGM as histopathologically Exclusion Criteria: - Patients who had contraindications with the use of steroids, those with active infections, as well as patients who were pregnant, and who had been diagnosed with breast cancer, were not included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
steroid injecting
Group L: Triamcinolone acetonide was administered to the patients through injecting inside the lesion.Group S: Oral methylprednisolone was administered to the patients.

Locations

Country Name City State
Turkey emine Yildirim Gaziosmanpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical response to the treatment Observational evaluation of the changes in terms of inflammation signs (hyperemia, edema, fever) 6 month
Primary Changes in the size of the mass The area of a mass captured by ultrasonography was calculated in cm^2 and the change in size was reported as a percentage 6 month
See also
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Recruiting NCT03766997 - Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM) Phase 4
Completed NCT04543149 - Immune Cells in Patients With Granulomatous Mastitis
Completed NCT03724903 - Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis N/A