Idiopathic Granulomatous Mastitis
Conditions
Keywords
Breast, Breast Conditions, Mastits, Granulomatous Mastitis, Inflammation, Breast Surgery, Rhematologist
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.
Interventions
DRUGPrednisolone
20mg of prednisolone will be prescribed, taken orally, and daily for first month followed by tapering doses of 15mg over one month, then 12.5mg for one month, proceeding to 10mg for one month, subsequently taking 7.5mg for one month, and lastly 5mg for one month.
DRUGMethotrexate
10mg of methotrexate will be prescribed to be taken once a week for one month. The dosage will be increased to 15mg of methotrexate taken once a week on the 1st (T1) month clinical visit and will be further increased to 20mg of methotrexate taken once a week on the 2nd (T2) month clinical visit. There will be no further escalation of dosage after this visit.
DRUGFolic Acid 5 MG
5mg of folic acid is to be taken together with methotrexate once a week.
DRUGOmeprazole 20 mg
Omeprazole will be prescribed at 20mg to protect the stomach lining.
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Evaluation of side effects. | 1 year | — |
| 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. |
| Evaluation of of treatment failure (TF) rate | 6 months | — |
| Evaluation of frequency of percutaneous or surgical intervention required | 6 months | — |
Countries
Singapore
Contacts
Primary ContactSerene Si Ning Goh, MBBS
Outcome results
None listed