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

Sponsor

Wuhan University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05395949

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Breast Diseases Mastitis Granulomatous Psychiatric Disorder	Drug: conservative treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jan 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Recurrence rate [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.
Breast appearance and cosmetic effect score [Up to 1 years]
Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.

Secondary Outcome Measures

recovery time [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China	430071

Sponsors and Collaborators

Wuhan University

Investigators

Study Director: Gaosong Wu, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaosong Wu, Ph D, MD, Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan University

ClinicalTrials.gov Identifier:

NCT05395949

Other Study ID Numbers:

GLMwPD

First Posted:

May 27, 2022

Last Update Posted:

May 27, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gaosong Wu, Ph D, MD, Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan University

granulomatous lobular mastitis ；Psychiatric Disorder；Steroid

Additional relevant MeSH terms:

Mastitis

Granulomatous Mastitis

Study Results

No Results Posted as of May 27, 2022