drugset / Trial / NCT06943482
Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-07-01
- Primary completion
- 2028-02-01
- Completion
- 2028-02-01
Publications
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 20 mg | — |
| Comparator | Prednisolone | Other / unclassified | 5 mg | Oral |
| Comparator | Omeprazole | Other / unclassified | 20 mg | — |
| Background | folic acid | Other / unclassified | 5 mg | — |