An interventional study of conservative treatment in Breast Diseases, Mastitis Granulomatous and Psychiatric Disorder, sponsored by Wuhan University. Enrolling by invitation at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Wuhan University · Not applicable, Interventional, and Treatment
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 .
22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.
This study's planned enrollment of 50 is below the median of 61 across 12 interventional studies indexed under Granulomatous Mastitis.
Browse Granulomatous Mastitis studies →Wuhan University is the lead sponsor of 46 studies on the registry; 14 are open to participants now.
Compared within Granulomatous Mastitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 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.
Time frame: Up to 1 years
recovery time
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
Time frame: Up to 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2019 (actual). Primary completion is estimated for Dec 2022, 47 months after the start.
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Wuhan University