Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease (IGM)

National University Health System (NUHS)

Status and phase: Begins enrollment in 1 month; Phase 4

Conditions: Idiopathic Granulomatous Mastitis

Treatments: Drug: Prednisolone; Drug: Omeprazole 20 mg; Drug: Folic Acid 5 MG; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT06943482

2023/00773

Details and patient eligibility

About

This research study is to determine the effectiveness of prednisolone and methotrexate for IGM patients over a period of one year, in terms of clinical and radiological response. Recruitment will be conducted in National University Hospital (NUH) for patients diagnosed with IGM.

Enrollment: 40 estimated patients

Sex: Female

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Women, aged between 21 and 60 years
• Positive diagnosis of idiopathic granulomatous mastitis based on histopathology results
• Willing and able to give informed consent

Exclusion Criteria (Patients who meet any of the following prerequisites will not be allowed to take part in this study):

• Women who are currently pregnant or breastfeeding
• Cognitive impairment which prevents the patient from giving voluntary consent
• History of any psychiatric conditions such as depression, psychosis, schizophrenia etc.
• History of cancer in the past 5 years
• History of abnormal renal or liver function
• History of diabetes mellitus
• History of pulmonary lung disease, pneumonitis, or related conditions
• Hepatitis B and/or Hepatitis C carrier
• Diagnosed with tuberculosis (Positive microbiological evaluation for Grocott Methenamine Silver stain and Ziehl- Neelsen stain)
• Any immunosuppressants or anti-inflammatory medications such as NSAIDS for the past 3 months
• Concomitant medication that may have contraindication with prednisolone and methotrexate use
• Hypersensitivity to components or drug products of prednisolone and methotrexate
• Vaccination with live virus vaccines prior to or during treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Steroid

Active Comparator group

Treatment:

Drug: Omeprazole 20 mg

Drug: Prednisolone

Methotrexate

Experimental group

Treatment:

Drug: Methotrexate

Drug: Folic Acid 5 MG