Could Intralesional Steroid be the Novel Treatment for Granulomatous Mastitis? (IGM)

• ClinicalTrials.gov Identifier: NCT04596046
• Recruitment Status: Completed
• First Posted: October 22, 2020
• Last Update Posted: October 22, 2020
• Sponsor: Gaziosmanpasa Research and Education Hospital
• Information provided by (Responsible Party): Emine Yıldırım, Gaziosmanpasa Research and Education Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Granulomatous Mastitis	Procedure: steroid injecting	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized-controlled study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of the Efficiency of Systemic Therapy and Intralesional Steroid Administration in the Treatment of Idiopathic Granulomatous Mastitis
• Actual Study Start Date: November 19, 2019
• Actual Primary Completion Date: June 15, 2020
• Actual Study Completion Date: July 17, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	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.
Experimental: 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	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.

Outcome Measures

Primary Outcome Measures :

1. Clinical response to the treatment [ Time Frame: 6 month ]
   Observational evaluation of the changes in terms of inflammation signs (hyperemia, edema, fever)
2. Changes in the size of the mass [ Time Frame: 6 month ]
   The area of a mass captured by ultrasonography was calculated in cm^2 and the change in size was reported as a percentage

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Turkey

emine Yildirim

Gaziosmanpasa, Istanbul, Turkey, 34255

Sponsors and Collaborators

Gaziosmanpasa Research and Education Hospital

More Information

• Responsible Party: Emine Yıldırım, Consultant General Surgeon, Gaziosmanpasa Research and Education Hospital
• ClinicalTrials.gov Identifier: NCT04596046
• Other Study ID Numbers: 95775
• First Posted: October 22, 2020
• Last Update Posted: October 22, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Abstracts

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emine Yıldırım, Gaziosmanpasa Research and Education Hospital:

Idiopathic granulomatous mastitis; intralesional steroid; systemic steroid

Additional relevant MeSH terms:

Mastitis; Granulomatous Mastitis; Puerperal Disorders; Pregnancy Complications; Breast Diseases; Skin Diseases