Could Intralesional Steroid be the Novel Treatment for Granulomatous Mastitis?

NCT ID: NCT04596046

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2020-07-17

Brief 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.

Detailed 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.

Conditions

Granulomatous Mastitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group S (systemic-peroral steroid)

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

Group Type: ACTIVE_COMPARATOR

steroid injecting

Intervention Type: PROCEDURE

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

Group L (local-intralesional steroid)

Triamcinolone acetonidewas administered to the patients through injecting inside the lesion. The practice was based on the dose of TCA administered in acute and chronic inflammatory skin lesions. If the lesion is single-focused and small (\<5.0 cm), 20mg / mL TCA was injected and if the lesion is multifocal or large (\>5.0 cm) then 40mg / mL TCA was injected into the lesion with the guidance of ultrasonography

Group Type: EXPERIMENTAL

steroid injecting

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Emine Yıldırım

Consultant General Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

emine Yildirim

Gaziosmanpaşa, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

95775

Identifier Type: -

Identifier Source: org_study_id