Daily topical inositol gel for breast pain after surgery
Official title: Evaluating the Effect of a Medical Device Based on Inositol in Improving Breast Pain
Run by Lo.Li.Pharma s.r.l · NCT07257770 · Data updated 2026-11-12
This trial will try a daily topical inositol gel to see if it reduces breast pain in women after breast surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Lo.Li.Pharma s.r.l Industry-sponsored |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | September 11, 2025 |
| Main results expected | April 11, 2026 |
| Study ends | July 11, 2026 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07257770 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–70 who had breast surgery at least 15 days earlier and who are experiencing breast pain linked to the surgical wound are ideal candidates.
✕Probably not a fit
Patients on ongoing systemic or local pain therapy, pregnant women, minors, or those with breast pain not related to a surgical wound are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study enrolls adult women (18–70) who report breast pain related to a surgical wound at least 15 days after breast surgery. Participants apply a medical device gel containing inositol to the affected area daily and record pain using a visual analogue scale (VAS). The primary approach is to compare pain scores before and after the local treatment over the study period. The trial is conducted at Policlinico Umberto I in Rome.
Why it matters
Potential benefit: If effective, the gel could offer a local, non‑systemic option to reduce postoperative breast pain.
How similar studies have gone: Topical inositol for postoperative mastalgia is largely novel and prior clinical evidence for this specific local application is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged between 18 and 70 years * Women who underwent breast surgery at least 15 days prior * Women experiencing breast pain associated with the surgical wound Exclusion Criteria: * Women under the age of 18 * Ongoing systemic and/or local pain therapy * Pregnant women
Where it's running
-
Policlinico Umberto I
Roma, Italy Recruiting
Study contacts
- Study coordinator: Maria Ida Amabile
- Email: mariaida.amabile@uniroma1.it
- Phone: +393290847775
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.