Back to resultsA Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders (GLMwPD)
Primary Purpose
Breast Diseases, Mastitis Granulomatous, Psychiatric Disorder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Breast Diseases focused on measuring granulomatous lobular mastitis ；Psychiatric Disorder；Steroid
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
Sites / Locations
- Zhongnan Hospital of Wuhan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Steroid combined with methotrexate
Extensive lesion excision
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Breast appearance and cosmetic effect score
Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05395949
Brief Title
A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
Acronym
GLMwPD
Official Title
A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases, Mastitis Granulomatous, Psychiatric Disorder
Keywords
granulomatous lobular mastitis ；Psychiatric Disorder；Steroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Steroid combined with methotrexate
Arm Type
Experimental
Arm Description
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.
Arm Title
Extensive lesion excision
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
conservative treatment
Intervention Description
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 Outcome Measure Information:
Title
Recurrence rate
Description
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
Title
Breast appearance and cosmetic effect score
Description
Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.
Time Frame
Up to 1 years
Secondary Outcome Measure Information:
Title
recovery time
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaosong Wu
Organizational Affiliation
Wuhan University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
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