An interventional study of DECLARAN cream in Breast Cancer, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Centro di Riferimento Oncologico - Aviano · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Patients will apply of DECLARAN cream is the investigational product based on NAC and urea
Other: DECLARAN cream
Patients will apply 1 mL of DECLARAN cream, as a single pressure dispensing (1 for hands, 1 for feet), 2 times/day on hands and feet, starting 3 days before the beginning of treatment with capecitabine and for the first 24 consecutive weeks of treatment.
To evaluate the role of NAC plus urea-based cream (DECLARAN) in the prevention of Capecitabine-induced HFS in patient affected by breast cancer.
Cumulative incidence of any grade HFS (according CTCAE vs 5.0,)
Time frame: up to 2 years
To evaluate severe HFS
Cumulative incidence of grade 3 HFS according CTCAE vs 5.0
Time frame: up to 2 years
To evaluate the impact of HFS on patients' quality of life at 6 weeks
Cumulative incidence of summary values of patient reported outcome (PRO) assessed with HFS-14 at 6 weeks
Time frame: up to 2 years
To evaluate the impact of HFS on patients' quality of life at 12 weeks
Cumulative incidence of summary values of patient reported outcome (PRO) assessed with HFS-14 at 12 weeks
Time frame: up to 2 years
To evaluate the impact of HFS on patients' quality of life at 24 weeks
Cumulative incidence of summary values of patient reported outcome (PRO) assessed with HFS-14 at 24 weeks
Time frame: up to 2 years
To evaluate the safety of NAC plus urea-based cream
Frequecies of adverse events
Time frame: up to 2 years
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Centro di Riferimento Oncologico - Aviano