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Study identifier: NCT06639178 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients

Condition: Breast Cancer  ·  Sponsor: Centro di Riferimento Oncologico - Aviano

PhaseNA
Planned participants25
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 Capec…

This description comes directly from the study's public registry record.

Talk to the study team

Simon Spazzapan, MD  ·  +39 0434 659725  ·  spazzapan@cro.it

Always discuss trial participation with your own doctor first.

Locations (2)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCSAviano, Pordenone, ItalyRecruiting
Azienda Sanitaria Universitaria del Friuli Centrale (ASUFC)Udine, ItalyNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06639178