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NCT Number: NCT06565845

Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis

Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.

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Key information

Conditions

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

Age range

15 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

Location status: Recruiting

Location contact

Yi Zhou

CONTACT

[email protected]

+86-0451-85552102

About this study

In recent years, the incidence of this disease has been increasing annually. The incidence of GLM is region-specific, being higher in Mediterranean regions and Asian countries. The etiology is currently unclear, but many studies suggest that GLM is associated with autoimmune disorders, hormonal imbalances, and microbial infections . GLM has a long course, is difficult to treat, and prone to recurrence, causing significant trauma to the patient's breast appearance and overall well-being. Currently, the main treatment methods for GLM include surgical treatment, drug therapy, combined surgery with drug therapy, and close observation. Surgical treatment options mainly include abscess incision and drainage, segmental resection, subcutaneous mastectomy, mastectomy, and breast reconstruction. Although surgical treatment can rapidly improve the condition, the recurrence rate reported in the literature ranges from 5% to 50% . Although GLM is a benign disease, it can severely impact the patient's normal life, causing physical and psychological trauma. However, few studies have included patients' subjective treatment experiences in the evaluation of treatment outcomes.

To date, there have been no studies comparing the efficacy of three treatment methods (surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy) in the same population of GLM patients. This study aims to compare the efficacy and patient satisfaction of these three treatment methods, with the hope of providing new insights for clinical treatment options.

Who can participate

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

Inclusion criteria

  • non-lactating and aged 15-65 years
  • histopathological confirmation of GLM
  • normal liver and kidney function

Exclusion criteria

  • lactating and pregnant women
  • allergies to rifampin, isoniazid, or ethambutol
  • concurrent malignant breast tumors
  • severe underlying diseases
  • other conditions deemed unsuitable by the investigator and
  • refusal to participate in the study

Treatment and study plan

Surgery

Procedure

patients underwent complete excision of the inflammatory breast tissue and some surrounding normal tissue under combined intravenous with inhalation anesthesia. Damaged skin was also removed.

triple anti-tuberculosis drug

Drug

Patients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day).

Primary outcomes

  1. Differences in the cure rate of the three treatment modalities

    Time frame: Baseline

    According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The cure rate was compared among the three groups.

  2. Differences in the recurrence rate of the three treatment modalities

    Time frame: Baseline

    According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The recurrence rate was compared among the three groups.

  3. Differences in the incidence of adverse reactions of the three treatment modalities

    Time frame: Baseline

    According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The incidence of adverse reactions was compared among the three groups.

Secondary outcomes

  1. Differences in the patient satisfaction score (points) of the three treatment modalities

    Time frame: Baseline

    According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The patient satisfaction score (points) was compared among the three groups.

  2. Differences in the treatment duration (months) of the three treatment modalities

    Time frame: Baseline

    According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The treatment duration (months) was compared among the three groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Zhou

CONTACT

[email protected]

+86-0451-85552102

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Harbin Medical University

Other

Registry information

Official study title

Analysis of the Clinical Characteristics and Three Treatment Methods of Granulomatous Lobular Mastitis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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