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

Официальное название

A Pilot Open-label Randomised Trial Comparing the Effectiveness of Steroids and Methotrexate for the Treatment of Idiopathic Granulomatous Mastitis

Обзор

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.

Вмешательства

• Препарат Prednisolone
  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.
• Препарат Methotrexate
  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.
• Препарат Folic Acid 5 MG
  5mg of folic acid is to be taken together with methotrexate once a week.
• Препарат Omeprazole 20 mg
  Omeprazole will be prescribed at 20mg to protect the stomach lining.

Первичные конечные точки

• Proportion of patients who achieved clinical or radiological complete response by 6 months [Срок оценки: 6 months]
• Time to clinical response and time to radiological response [Срок оценки: 6 months]
• Proportion of patients with relapse in a year within affected breast between each arm. [Срок оценки: 1 year]

Вторичные конечные точки (7)

• Evaluation of side effects. [Срок оценки: 1 year]
• Evaluation of of treatment failure (TF) rate [Срок оценки: 6 months]
• Evaluation of frequency of percutaneous or surgical intervention required [Срок оценки: 6 months]
• Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response [Срок оценки: 3 years]
• Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR) [Срок оценки: 3 years]
• Evaluation of patient reported outcome measures [Срок оценки: 3 years]
• Validate survey instrument for IGM patients [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• National University Hospital — Singapore

Публикации

• 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. PMID 25516860
• 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
• 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
• 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. PMID 31968055
• 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. PMID 36865415
• 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. PMID 22872797
• 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. PMID 34602947
• 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. PMID 12662235

Идентификаторы

NCT: NCT06943482 · 2023/00773

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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