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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid | Active Comparator |
| |
| Methotrexate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of side effects. | 1 year | |
| Evaluation of of treatment failure (TF) rate | 6 months | |
| Evaluation of frequency of percutaneous or surgical intervention required |
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Inclusion Criteria:
Exclusion Criteria (Patients who meet any of the following prerequisites will not be allowed to take part in this study):
Women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serene Si Ning Goh, MBBS | Contact | +65 9100 6954 | serene_sn_goh@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Serene Si Ning Goh, MBBS | National | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25516860 | Background | Altintoprak F, Kivilcim T, Ozkan OV. Aetiology of idiopathic granulomatous mastitis. World J Clin Cases. 2014 Dec 16;2(12):852-8. doi: 10.12998/wjcc.v2.i12.852. | |
| Background | Manogna, P., Dev, B., Joseph, L.D. et al. Idiopathic granulomatous mastitis-our experience. Egypt J Radiol Nucl Med 51, 15 (2020). https://doi.org/10.1186/s43055-019-0126-4 | ||
| Background | Kehribar, D. Y., Duran, T. I., Cetinkaya, G. K., Polat, A. K., Ozgen, M. (2020). Evaluation of Symptoms, Depression and Anxiety Levels in Young Women with Idiopathic Granulomatous Mastitis. Int J Acad Med Pharm, 2(2), 57-61. https://doi.org/10.29228/jamp.42734 | ||
| 31968055 |
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|
| Methotrexate | Drug | 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. |
|
| Folic Acid 5 MG | Drug | 5mg of folic acid is to be taken together with methotrexate once a week. |
|
| Omeprazole 20 mg | Drug | Omeprazole will be prescribed at 20mg to protect the stomach lining. |
|
| 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) | 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 | 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. | 3 years |
| 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. | 3 years |
| Background |
| Steuer AB, Stern MJ, Cobos G, Castilla C, Joseph KA, Pomeranz MK, Femia AN. Clinical Characteristics and Medical Management of Idiopathic Granulomatous Mastitis. JAMA Dermatol. 2020 Apr 1;156(4):460-464. doi: 10.1001/jamadermatol.2019.4516. |
| 36865415 | Background | Al Awfi MM, Al Rahbi SK. Idiopathic Granulomatous Mastitis: Six years of experience and the current evidence in literature. Sultan Qaboos Univ Med J. 2023 Feb;23(1):36-41. doi: 10.18295/squmj.4.2022.030. Epub 2023 Feb 23. |
| 22872797 | Background | Kayahan M, Kadioglu H, Muslumanoglu M. Management of Patients with Granulomatous Mastitis: Analysis of 31 Cases. Breast Care (Basel). 2012 Jun;7(3):226-230. doi: 10.1159/000337758. Epub 2012 Jun 27. |
| 34602947 | Background | Kafadar MT, Bahadir MV, Girgin S. Low-Dose Methotrexate Use in Idiopathic Granulomatous Mastitis: An Alternative Treatment Method. Breast Care (Basel). 2021 Aug;16(4):402-407. doi: 10.1159/000513879. Epub 2021 Jan 22. |
| 12662235 | Background | Kim J, Tymms KE, Buckingham JM. Methotrexate in the management of granulomatous mastitis. ANZ J Surg. 2003 Apr;73(4):247-9. doi: 10.1046/j.1445-1433.2002.02564.x. |
| 31203215 | Background | Postolova A, Troxell ML, Wapnir IL, Genovese MC. Methotrexate in the Treatment of Idiopathic Granulomatous Mastitis. J Rheumatol. 2020 Jun 1;47(6):924-927. doi: 10.3899/jrheum.181205. Epub 2019 Jun 15. |
| 25751209 | Background | Sheybani F, Sarvghad M, Naderi H, Gharib M. Treatment for and clinical characteristics of granulomatous mastitis. Obstet Gynecol. 2015 Apr;125(4):801-807. doi: 10.1097/AOG.0000000000000734. |
| ID | Term |
|---|---|
| D058890 | Granulomatous Mastitis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D008413 | Mastitis |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D008727 | Methotrexate |
| D005492 | Folic Acid |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
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