Trial Title:
Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients
NCT ID:
NCT06639178
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Hand-Foot Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
DECLARAN cream
Description:
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.
Arm group label:
DECLARAN cream
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Simon Spazzapan, MD
Phone:
+39 0434 659725
Email:
spazzapan@cro.it
Investigator:
Last name:
Simon Spazzapan, MD
Email:
Principal Investigator
Investigator:
Last name:
Camilla Lisanti
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Universitaria del Friuli Centrale (ASUFC)
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elena Poletto, MD
Phone:
+39 0432 552761
Email:
elena.poletto@asufc.sanita.fvg.it
Investigator:
Last name:
Elena Poletto, MD
Email:
Principal Investigator
Start date:
August 1, 2024
Completion date:
May 15, 2026
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06639178
