Breast DiseasesGLMwPDNCT05395949
A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
A study testing conservative treatment in people with Breast Diseases and Mastitis Granulomatous, run by Wuhan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Diseases, Mastitis Granulomatous, Psychiatric Disorder
- What is being tested?
- conservative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 years or older with granulomatous lobular mastitis
- Patients with Psychiatric Disorders;
- Patients volunteered to participate in the study after informed consent.
Who cannot join
- Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
- Patients in acute exacerbation of mental illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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 .
- Being tested
- conservative treatment
- Keywords
- granulomatous lobular mastitis ；Psychiatric Disorder；Steroid
- Medical subject headings
- Breast Diseases, Granulomatous Mastitis, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 years
Secondary outcomes (1)
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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jan 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaosong Wu, Ph D, MD, Wuhan University
- Investigators
- Gaosong Wu, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395949
- Sponsor's protocol ID
- GLMwPD
- Acronym
- GLMwPD
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT05395949
- Acronym / sponsor ID
- GLMwPD / GLMwPD
- Keywords
- granulomatous lobular mastitis ；Psychiatric Disorder；Steroid
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid combined with methotrexate | Experimental | Drug: conservative treatmentPrednisone 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older with granulomatous lobular mastitis
- Patients with Psychiatric Disorders;
- Patients volunteered to participate in the study after informed consent.
Key exclusion criteria (2 listed)
- Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
- Patients in acute exacerbation of mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conservative treatmentPrednisone 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 | Steroid combined with methotrexate |
Primary outcome
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.
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.
1 secondary outcome
recovery time
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaosong Wu study director
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conservative treatment in people with Breast Diseases and Mastitis Granulomatous, run by Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: Up to 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.