Idiopathic Granulomatous Mastitis Combination Therapy

NCT05361629 | Unknown DMC

• 1 other identifier: MF 22-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

After breast cancer, diopathic Granulomatous Mastitis (IGM) is among the breast diseases that bother patients and clinicians the most. Countries with a coast to the Mediterranean, especially our country, are the most common geography of this disease. For this reason, a significant part of the important scientific publications about IGM in the last 3-4 decades are from the countries of this geography and mainly from our country. The paradigm of whether IGM should be treated medically or surgically is still a matter of debate. Today, effective treatment results can be achieved with medical treatments, and local drug applications are finding an increasing application area in order to reduce the systemic drug level due to the side effects often seen in this process. As in the centers dealing with breast diseases intensively in our country, patients are treated in our center both by systemic and local means. Within the body of the Turkish Breast Diseases Federation, after the plans made with the employees of the leading breast centers of the International Breast Health Working Group International planned to start a recording study to observe the activity between, local treatment in the lesion without surgical treatment with systemic treatment in IGM treatment and local treatment together with surgical treatment.

Conditions

Idiopathic Granulomatous Mastitis

Keywords

Idiopathic granulomatous mastitis; Steroid injection; Topical steroid; Steroid injection to surgical cavity

Outcome Measures

Primary Outcomes (1)

• The effect of excision and intraoperative steroid administration to the cavity in Idiopathic Granulomatous Mastitis.

  The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on outcome in Idiopathic Granulomatous Mastitis.

  one year

Secondary Outcomes (2)

• Rate of side effects in patients who received intralesional steroid

  one year

• Correlation of treatment modality and serum cortisol levels.

  one year

Study Arms (2)

NON-SURGERY GROUP

ACTIVE COMPARATOR

Group 1: Patients whose serum cortisol level was observed before starting the treatment, who were injected with 40 mg of prednol at 4 weeks intervals for 3 months for each lesion. The total monthly dose will not exceed 120 mg, and the total 3-month dose will not exceed 200 mg. In this group of patients, the serum cortisol level should have reappeared on the 2nd or 3rd day following each intralesional administration. In this group of patients, low-dose oral prednol (\<30 mg/day) and/or topical prednol cream can be applied twice a day during the treatment.

Procedure: Intralesional steroid administration

SURGERY GROUP

ACTIVE COMPARATOR

In patients included in Group 2, serum cortisol levels should have been observed before starting treatment. Then the patients should be operated and the mass(s) should be excised. Intraoperatively, not less than 40 mg of prednol should be injected into each mass cavity (it may vary according to the cavity diameter), and the amount applied to all cavities should not exceed 200 mg in total. The amount of prednol administered for each cavity should be recorded. In this group of patients, prednol may have been administered to the cavity walls (Group 2a) or inside the cavity (Group 2b). Serum cortisol levels should be seen in patients 7 to 10 days after the procedure. Group 2a: 4 Quadrants 40 mg predmol per cavity wall (for \< 2cm lesion and an additional 20 mg for each additional 1 cm) Group 2b: 40 mg predmol into the cavity (for \< 2 cm lesion and an additional 20 mg for each additional 1 cm)

Procedure: Intraoperative cavity steroid administration

Interventions

Intralesional steroid administration PROCEDURE

Treatment by administering steroids into the lesion

NON-SURGERY GROUP

Intraoperative cavity steroid administration PROCEDURE

Treatment by administering steroids into the surgical cavity

SURGERY GROUP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with IGM histopathologically
• Patients in groups A, B and C according to clinical classification
• Ultrasonographically; Patients with leaf-like hypoechoic type, localized abscess type, and localized hypoechoic mass type mastitis

You may not qualify if:

• Patients diagnosed with tumor after biopsy
• Those with TB PCR (+)
• Presence of clinically widespread abscess and cellulite (group D patients)
• Ultrasonographically; diffuse diffuse type
• Pregnancy
• Breastfeeding period

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Adana Teaching Hospital

Adana, Yuregir, 01120, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Hu T, Li S, Huang H, Huang H, Tan L, Chen Y, Deng H, Wu J, Zhu L, Zhang J, Su F, Chen K. Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. BMJ Open. 2020 Oct 10;10(10):e036643. doi: 10.1136/bmjopen-2019-036643.

  PMID: 33039992 RESULT

• Ma X, Min X, Yao C. Different Treatments for Granulomatous Lobular Mastitis: A Systematic Review and Meta-Analysis. Breast Care (Basel). 2020 Feb;15(1):60-66. doi: 10.1159/000501498. Epub 2019 Jul 10.

  PMID: 32231499 RESULT

• Zhou F, Liu L, Liu L, Yu L, Wang F, Xiang Y, Zheng C, Huang S, Cai H, Yu Z. Comparison of Conservative versus Surgical Treatment Protocols in Treating Idiopathic Granulomatous Mastitis: A Meta-Analysis. Breast Care (Basel). 2020 Aug;15(4):415-420. doi: 10.1159/000503602. Epub 2019 Oct 22.

  PMID: 32982653 RESULT

• Wang Y, Song J, Tu Y, Chen C, Sun S. Minimally invasive comprehensive treatment for granulomatous lobular mastitis. BMC Surg. 2020 Feb 22;20(1):34. doi: 10.1186/s12893-020-00696-w.

  PMID: 32087717 RESULT

Study Officials

• Ozgur Aytac, MD

  Baskent University

  STUDY DIRECTOR

Central Study Contacts

Ozgur Aytac, MD

CONTACT

905326529343; oaytac@gmail.com

Mehmet A Mazlı, MD

CONTACT

05327346195; mnazli46@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 5, 2022
• Study Start: April 16, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)