A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders

NCT ID: NCT05395949

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2027-01-30

Brief Summary

Granulomatous lobular mastitis (GLM) is a relatively rare chronic inflammatory disease of the breast in clinical practice. A small number of patients develop hyperprolactinemia during psychiatric drug treatment, and most of these patients are nulliparous. At present, there is no unified treatment mode at home and abroad, and surgery is generally the main treatment. GLM is a sterile inflammation, and glucocorticoids and methotrexate can effectively relieve clinical symptoms and even reach the standard of cure. In order to reduce the recurrence rate and protect the breast appearance as much as possible, we propose a conservative therapy. The purpose of this study was to compare this conservative therapy of granulomatous lobular mastitis with existing surgical treatment, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients with psychiatric disorders .

Conditions

Breast Diseases; Mastitis Granulomatous; Psychiatric Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Steroid combined with methotrexate

Prednisone 30 mg/day, supplemented with calcium and omeprazole, and Prednisone were slowly reduced to 10 mg/day after symptoms were relieved, and combined with 7.5 mg/week MTX therapy.

Group Type: EXPERIMENTAL

conservative treatment

Intervention Type: DRUG

Prednisone 30 mg/day, supplemented with calcium and omeprazole, and Prednisone were slowly reduced to 10 mg/day after symptoms were relieved, and combined with 7.5 mg/week MTX therapy.

Extensive lesion excision

Patients in the control group underwent wide local excision, make sure the margin is negative. Irrigation and mammoplasty were performed in the same way as in the observation group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

conservative treatment

Prednisone 30 mg/day, supplemented with calcium and omeprazole, and Prednisone were slowly reduced to 10 mg/day after symptoms were relieved, and combined with 7.5 mg/week MTX therapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years or older with granulomatous lobular mastitis
• Patients with Psychiatric Disorders;
• Patients volunteered to participate in the study after informed consent.

Exclusion Criteria

• Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
• Patients in acute exacerbation of mental illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Gaosong Wu, Ph D, MD

Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaosong Wu

Role: STUDY_DIRECTOR

Wuhan University

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

GLMwPD

Identifier Type: -

Identifier Source: org_study_id