Daily topical inositol gel for breast pain after surgery
Evaluating the Effect of a Medical Device Based on Inositol in Improving Breast Pain
This trial will try a daily topical inositol gel to see if it reduces breast pain in women after breast surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Lo.Li.Pharma s.r.l Industry-sponsored |
| Locations | 1 site (Roma) |
| Trial ID | NCT07257770 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Topical inositol for postoperative mastalgia is largely novel and prior clinical evidence for this specific local application is limited.
Eligibility criteria
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 this trial is running
Roma
- Policlinico Umberto I — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Maria Ida Amabile
- Email: mariaida.amabile@uniroma1.it
- Phone: +393290847775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.