Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients
- Conditions
- Breast Cancer
- Registration Number
- NCT06639178
- Lead Sponsor
- Centro di Riferimento Oncologico - Aviano
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the role of NAC plus urea-based cream (DECLARAN) in the prevention of Capecitabine-induced HFS in patient affected by breast cancer. up to 2 years Cumulative incidence of any grade HFS (according CTCAE vs 5.0,)
- Secondary Outcome Measures
Name Time Method To evaluate severe HFS up to 2 years Cumulative incidence of grade 3 HFS according CTCAE vs 5.0
To evaluate the impact of HFS on patients' quality of life at 6 weeks up to 2 years Cumulative incidence of summary values of patient reported outcome (PRO) assessed with HFS-14 at 6 weeks
To evaluate the impact of HFS on patients' quality of life at 12 weeks up to 2 years Cumulative incidence of summary values of patient reported outcome (PRO) assessed with HFS-14 at 12 weeks
To evaluate the impact of HFS on patients' quality of life at 24 weeks up to 2 years Cumulative incidence of summary values of patient reported outcome (PRO) assessed with HFS-14 at 24 weeks
To evaluate the safety of NAC plus urea-based cream up to 2 years Frequecies of adverse events
Trial Locations
- Locations (2)
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
🇮🇹Aviano, Pordenone, Italy
Azienda Sanitaria Universitaria del Friuli Centrale (ASUFC)
🇮🇹Udine, Italy