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.
