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

NCT06639178 | Recruiting

• 1 other identifier: CRO-2023-28
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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,)

  up to 2 years

Secondary Outcomes (5)

• To evaluate severe HFS

  up to 2 years

• To evaluate the impact of HFS on patients' quality of life at 6 weeks

  up to 2 years

• To evaluate the impact of HFS on patients' quality of life at 12 weeks

  up to 2 years

• To evaluate the impact of HFS on patients' quality of life at 24 weeks

  up to 2 years

• To evaluate the safety of NAC plus urea-based cream

  up to 2 years

Study Arms (1)

DECLARAN cream

EXPERIMENTAL

Patients will apply of DECLARAN cream is the investigational product based on NAC and urea

Other: DECLARAN cream

Interventions

DECLARAN cream OTHER

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.

DECLARAN cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (2)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

Azienda Sanitaria Universitaria del Friuli Centrale (ASUFC)

Udine, 33100, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Simon Spazzapan, MD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

• Camilla Lisanti, MD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Spazzapan, MD

CONTACT

+39 0434 659725; spazzapan@cro.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

IT (2)