Monitoring mild non-lactational mastitis without immediate treatment

Observation Alone for Mild Non-Lactational Mastitis: A Cohort Study.

This study is tracking how mild non-lactational mastitis changes over time in patients who aren't getting immediate treatment to see if just watching the condition is a good first step.

Quick facts

• Study type: Observational
• Enrollment: 57 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06665399 on ClinicalTrials.gov

What this trial studies

This observational study aims to track the progression of mild Non-Lactational Granulomatous Lobular / Periductal Mastitis (NL-GLM/PDM) in patients who are not receiving immediate treatment. Participants will be monitored over time to assess the rate of disease progression and identify clinical and pathological factors associated with any changes in their condition. The study seeks to provide insights into the effectiveness of an observation strategy as a first-line approach for managing mild cases of this inflammatory breast disease. Data collected will help inform future clinical practices and research directions.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 65 with a clinical diagnosis of mild non-lactational granulomatous lobular or periductal mastitis.

Not a fit: Patients with confirmed or suspected breast malignancy or those with bilateral mastitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help establish observation as a safe and effective management strategy for patients with mild NL-GLM/PDM.

How similar studies have performed: Other studies have suggested that observation can be effective for mild cases of NL-GLM/PDM, indicating this approach may be viable.

Eligibility criteria

Inclusion Criteria:

1. Female, aged 18 to 65 years;
2. Clinically diagnosed with possible non-lactational (more than 6 months since stopping breastfeeding) granulomatous lobular mastitis or periductal mastitis.
3. Mscore ≤ 3 points;
4. Patients with ultrasound findings suggesting localized breast abscess formation must have undergone abscess drainage before enrollment;
5. After education, participants should have a strong willingness for observation and follow-up, and, after discussing with the primary physician, jointly decide to proceed with observation and follow-up;
6. Signed informed consent form.

Exclusion Criteria:

1. Patients with confirmed or suspected breast malignancy;
2. Patients with bilateral mastitis (including those with bilateral simultaneous onset and those with sequential onset of non-lactational granulomatous mastitis);
3. Pregnant patients who are currently in the gestation period;
4. Patients who have had non-lactational mastitis in the same breast within the past year and have undergone treatments such as surgery, oral corticosteroids (for more than 2 weeks), anti-tuberculosis treatment (for more than 2 weeks), or ductal lavage therapy.
5. Patients who received surgery, oral corticosteroids, or anti-tuberculosis treatment for the non-lactational mastitis of the ipsilateral breast within 2 weeks before enrollment.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Shenshan Medical Center, Sun Yat-sen Memorial Hospital — Shanwei, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Kai Chen, MD

Conditions Granulomatous Mastitis; Mastitis Chronic; Granulomatous Mastitis, Observation, Treatment; Periductal mastitis