NCT06639178 Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients
| NCT ID | NCT06639178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro di Riferimento Oncologico - Aviano |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-08-01 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast cancer (BC) is the most frequent tumour in women. To date, among the available treatments, the use of Capecitabine, an oral prodrug of fluorouracil, has been shown activity in different setting. In advanced disease, Capecitabine is often used as monotherapy in patients pretreated with anthracycline, taxane or both. One of the most frequent toxicities reported by patients receiving capecitabine is hand-foot syndrome (HFS), with an incidence of grade 3 HFS of 28%. HFS, also known as palmar-plantar erythrodysesthesia syndrome, is initially characterized by palmoplantar numbness, tingling, or burning pain. These symptoms usually coincide with sharply demarcated erythema with or without edema, cracking, or desquamation. In advanced stages, blistering and ulceration may occur. Although HFS is not considered life threatening, it can be painful and interfere with daily activities, thusseriously compromising quality of life (QoL), therefore this toxicity is considered dose limiting.Moreover, consistent with the theory that Capecitabine and its metabolites induce an inflammatory effect, the use of COX-2 inhibitors is an emerging strategies, but more evidence are needed from largest study to confirm their efficacy. Similarly, N-acetylcysteine (NAC), an antioxidant, mucolytic and nephroprotective agent, that affects pathways involved in inflammatory conditions and that has demonstrated to be effective in several dermatologic conditions, could be useful in the management of Capecitabine-induced HFS. From this arises the present study that has the objective of evaluating the role of NAC plus urea-based cream in the prevention of Capecitabineinduced HFS in patient affected by breast cancer.
Eligibility 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
Contact & Investigator
Simon Spazzapan, MD
PRINCIPAL INVESTIGATOR
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
Frequently Asked Questions
Who can join the NCT06639178 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06639178 currently recruiting?
Yes, NCT06639178 is actively recruiting participants. Contact the research team at spazzapan@cro.it for enrollment information.
Where is the NCT06639178 trial being conducted?
This trial is being conducted at Aviano, Italy, Udine, Italy.
Who is sponsoring the NCT06639178 clinical trial?
NCT06639178 is sponsored by Centro di Riferimento Oncologico - Aviano. The principal investigator is Simon Spazzapan, MD at Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS. The trial plans to enroll 25 participants.
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