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

Phase 4

Not yet recruiting

• Conditions: Idiopathic Granulomatous Mastitis
• Interventions: Drug: Prednisolone; Drug: Methotrexate; Drug: Omeprazole 20 mg; Drug: Folic Acid 5 MG

• Registration Number: NCT06943482
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-07-01
• Primary Completion: 2028-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid	Prednisolone	-
Steroid	Omeprazole 20 mg	-
Methotrexate	Methotrexate	-
Methotrexate	Folic Acid 5 MG	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients who achieved clinical or radiological complete response by 6 months	6 months
Time to clinical response and time to radiological response	6 months
Proportion of patients with relapse in a year within affected breast between each arm.	1 year

Secondary Outcome Measures

Name	Time	Method
Evaluation of side effects.	1 year
Evaluation of of treatment failure (TF) rate	6 months
Evaluation of frequency of percutaneous or surgical intervention required	6 months
Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response	3 years
Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR)	3 years	Depending on the biomarkers tested, there will be different unit of measurements. Some examples of biomarkers that may be tested are: CRP: mg/l IL-6: pg/ml NLR: ratio
Validate survey instrument for IGM patients	3 years	The survey is adopted from SF-36 for general health and EORTC BR23 for body image, breast health and pain.
Evaluation of patient reported outcome measures	3 years	Most of our questions are on a scale from 1 - 5, with some yes or no question and an open question at the end.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore