Watchful waiting may be enough for mild mastitis
NCT ID NCT06665399
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study followed 57 women with mild non-lactational mastitis (breast inflammation not related to breastfeeding) to see if simply monitoring the condition without active treatment is safe. Participants did not receive surgery, steroids, or antibiotics, but could use pain relievers. The goal was to measure how many women got worse within 12 weeks and what factors might predict progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could show that many mild cases of this breast inflammation can be safely monitored without aggressive treatments, reducing unnecessary interventions.
- What could go wrong
- This is a small, completed observational study with only 57 participants. It does not test a new treatment, so it cannot prove what works best. Results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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57 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with non-lactational mastitis (defined as more than 6 months since stopping breastfeeding) who meet the eligibility criteria at the Breast Tumor Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ≤ 4 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shenshan Medical Center, Sun Yat-sen Memorial Hospital
Shanwei, Guangdong, 516600, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
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