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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
5mg of folic acid is to be taken together with methotrexate once a week.
National University Hospital
Singapore, Singapore
Proportion of patients who achieved clinical or radiological complete response by 6 months
Time frame: 6 months
Time to clinical response and time to radiological response
Time frame: 6 months
Proportion of patients with relapse in a year within affected breast between each arm.
Time frame: 1 year
Evaluation of side effects.
Time frame: 1 year
Evaluation of of treatment failure (TF) rate
Time frame: 6 months
Evaluation of frequency of percutaneous or surgical intervention required
Time frame: 6 months
Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response
Time frame: 3 years
Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR)
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
Time frame: 3 years
Evaluation of patient reported outcome measures
Most of our questions are on a scale from 1 - 5, with some yes or no question and an open question at the end.
Time frame: 3 years
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Omeprazole will be prescribed at 20mg to protect the stomach lining.
Validate survey instrument for IGM patients
The survey is adopted from SF-36 for general health and EORTC BR23 for body image, breast health and pain.
Time frame: 3 years