Clinical trial NCT03766997: Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)
Official title: A Randomized Controlled Study on the Effectiveness of Local Injection Combined With Topical Steroids vs. Topical Steroids Mono-therapy in the Treatment of Idiopathic Granulomatous Mastitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Granulomatous Mastitis
Keywords: Granulomatous Mastitis
local injection
topical steroids
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the clinical response rate of local steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive local injection combined with topical steroids and the other half will receive topical steroids mono-therapy.

Detailed description: Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.Clinical presentation of IGM can be variable. Some findings may be confused with breast malignancy.

Although IGM as a disease has been known for nearly four decades, no treatment consensus has been reached because of its rarity. Surgical treatment, antibiotics, oral steroids, topical steroids, immunosuppression (methotrexate, mycophenolate mofetil) and close follow up have all been reported to be effective.

Currently,surgical treatment and systemic steroids treatment are most frequently employed. With the consideration of side effects of long term systemic (oral) steroid usage, topical steroids without systemic use were assessed and showed satisfactory curative effect. But there is no data concerning the use of local injection of steroids therapy on IGM.The purpose of this study is to evaluate the effectiveness of steroids local injection on the basis of topical steroids for IGM treatment.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Granulomatous Mastitis
* Require non-surgical treatment

Exclusion Criteria:

* Breast Carcinoma

Primary outcomes:
measure: clinical response rate
timeFrame: six months
Secondary outcomes:
measure: granulomatous mastitis recurrence
timeFrame: two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Breast Surgery,Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Qiang Sun, Master
role: STUDY_DIRECTOR
References:
citation: Tahmasebi S, Karami MY, Maalhagh M. Granulomatous Mastitis: Time to Introduce New Weapons. World J Surg. 2016 Nov;40(11):2827-2828. doi: 10.1007/s00268-016-3438-9. No abstract available.
citation: Altintoprak F, Kivilcim T, Yalkin O, Uzunoglu Y, Kahyaoglu Z, Dilek ON. Topical Steroids Are Effective in the Treatment of Idiopathic Granulomatous Mastitis. World J Surg. 2015 Nov;39(11):2718-23. doi: 10.1007/s00268-015-3147-9.
citation: Sheybani F, Naderi HR, Gharib M, Sarvghad M, Mirfeizi Z. Idiopathic granulomatous mastitis: Long-discussed but yet-to-be-known. Autoimmunity. 2016 Jun;49(4):236-9. doi: 10.3109/08916934.2016.1138221. Epub 2016 Feb 1.
citation: Benson JR, Dumitru D. Idiopathic granulomatous mastitis: presentation, investigation and management. Future Oncol. 2016 Jun;12(11):1381-94. doi: 10.2217/fon-2015-0038. Epub 2016 Apr 12.