Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2021

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.

Interventions

  • Drug: Compound Betamethasone Injection
    • local injection
  • Drug: Hydrocortisone Butyrate 0.1% Cream
    • topical use

Arms, Groups and Cohorts

  • Experimental: local injection
    • Compound betamethasone injection (Each injection contains betamethasone dipropionate at 5 mg for betamethasone and betamethasone sodium phosphate at 2 mg for betamethasone) was local injected to the breast by the patient once a week for one to four times followed by Hydrocortisone butyrate cream(0.1%) topical use twice a day until the termination of treatment.
  • Active Comparator: topical
    • Hydrocortisone butyrate 0.1% cream was applied to the breast by the patient twice a day until the termination of treatment.

Clinical Trial Outcome Measures

Primary Measures

  • clinical response rate
    • Time Frame: six months
    • The clinical response is categorized into ”completely healed,” ”inadequately healed,” ”stable,” ”worsened,” or ”relapsed” if the lesions had once healed but symptoms returned.

Secondary Measures

  • granulomatous mastitis recurrence
    • Time Frame: two years
    • IGM relapses in the Ipsilateral breast.

Participating in This Clinical Trial

Inclusion Criteria

  • Idiopathic Granulomatous Mastitis
  • Require non-surgical treatment

Exclusion Criteria

  • Breast Carcinoma

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Qiang Sun, Master, Study Director, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Yanna Zhang, M.D., 86-10-69158703, pumchzyn@sohu.com

References

Tahmasebi S, Karami MY, Maalhagh M. Granulomatous Mastitis: Time to Introduce New Weapons. World J Surg. 2016 Nov;40(11):2827-2828.

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.

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. Review.

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. Review.

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