N-acetylcysteine and Urea cream for preventing hand-foot syndrome in breast cancer patients on Capecitabine
Phase II Trial to Determine the Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients
This study is testing a cream with N-acetylcysteine and urea to see if it can help prevent painful hand-foot syndrome in breast cancer patients taking Capecitabine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Locations | 2 sites (Aviano, Pordenone and 1 other locations) |
| Trial ID | NCT06639178 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a cream containing N-acetylcysteine and urea in preventing hand-foot syndrome (HFS) in breast cancer patients undergoing treatment with Capecitabine. HFS is a common and painful side effect that can significantly impact the quality of life for patients receiving this chemotherapy. The study will enroll patients diagnosed with breast cancer who are scheduled to receive Capecitabine, and they will apply the cream as part of their treatment regimen. The goal is to assess whether this topical intervention can reduce the incidence and severity of HFS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of breast cancer who are scheduled to receive Capecitabine treatment.
Not a fit: Patients who have previously been treated with drugs that may induce hand-foot syndrome or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for breast cancer patients by reducing the painful side effects associated with Capecitabine.
How similar studies have performed: While there is emerging evidence for the use of COX-2 inhibitors in managing HFS, the specific use of N-acetylcysteine in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women and men ≥18 years old * Patients with diagnosis of breast cancer with stage I-III radically operated with residual disease post neoadjuvant treatment or stage IV * Patients candidated for capecitabine in a post-neoadjuvant or metastatic setting treated with 2000-2500 mg/m2 d1-14 q21, or 1500 mg daily continuously (metronomic schedule) * Patients who provided written informed consent Exclusion Criteria: * Patients previously treated with drugs that may have induced HFS * Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol * Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatmen
Where this trial is running
Aviano, Pordenone and 1 other locations
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano, Pordenone, Italy (Recruiting)
- Azienda Sanitaria Universitaria del Friuli Centrale (ASUFC) — Udine, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Simon Spazzapan, MD — Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
- Study coordinator: Simon Spazzapan, MD
- Email: spazzapan@cro.it
- Phone: +39 0434 659725
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.