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Enrolling by Invitation

NCT Number: NCT05395949

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

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 .

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Key information

Conditions

Breast Diseases Female Urogenital Diseases and Pregnancy Complications Granulomatous Mastitis Mastitis Mastitis Granulomatous Mental Disorders Pregnancy Complications Psychiatric Disorder Puerperal Disorders Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recurrence rate

    Time frame: Up to 1 years

    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.

  2. Breast appearance and cosmetic effect score

    Time frame: Up to 1 years

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

Secondary outcomes

  1. recovery time

    Time frame: Up to 2 years

    the timing of the disappearance of the symptoms including Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Acronym: GLMwPD

Important dates

Study start
2019
Primary completion
2022
Study completion
2027
First posted
May 27, 2022
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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