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

NCT05395949 | Enrolling By Invitation

• 1 other identifier: GLMwPD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

granulomatous lobular mastitis ；Psychiatric Disorder；Steroid

Outcome Measures

Primary Outcomes (2)

• Recurrence rate

  Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast within one year after surgery was defined as recurrence.

  Up to 1 years

• Breast appearance and cosmetic effect score

  Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.

  Up to 1 years

Secondary Outcomes (1)

• recovery time

  Up to 2 years

Study Arms (2)

Steroid combined with methotrexate

EXPERIMENTAL

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.

Drug: conservative treatment

Extensive lesion excision

NO INTERVENTION

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.

Interventions

conservative treatment 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.

Steroid combined with methotrexate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Breast Diseases; Granulomatous Mastitis; Mental Disorders

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Mastitis; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gaosong Wu

  Wuhan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: January 1, 2019
• Primary Completion: December 30, 2022
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)