Breast CancerHAND-TO-HANDNCT06639178
Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients
A study testing DECLARAN cream in people with Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DECLARAN cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Aug 2024to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Aviano, Pordenone, 33081
Simon Spazzapan, MD, +39 0434 659725, spazzapan@cro.it
Simon Spazzapan, MD
- Not yet recruiting
Azienda Sanitaria Universitaria del Friuli Centrale (ASUFC)
Udine, 33100
Elena Poletto, MD, +39 0432 552761, elena.poletto@asufc.sanita.fvg.it
Elena Poletto, MD
About this study
Official title: Phase II Trial to Determine the Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- DECLARAN cream
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECLARAN creamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DECLARAN cream | Experimental | Patients will apply of DECLARAN cream is the investigational product based on NAC and urea Receives: Other: DECLARAN cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,)
Measured: up to 2 years
Secondary outcomes (5)
To evaluate severe HFS
Cumulative incidence of grade 3 HFS according CTCAE vs 5.0
Measured: 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
Measured: 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
Measured: 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
Measured: up to 2 years
To evaluate the safety of NAC plus urea-based cream
Frequecies of adverse events
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Aug 2024
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Spazzapan, MD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCSCamilla Lisanti, MD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639178
- Sponsor's protocol ID
- CRO-2023-28
- Acronym
- HAND-TO-HAND
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial to Determine the Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06639178
- Acronym / sponsor ID
- HAND-TO-HAND / CRO-2023-28
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DECLARAN cream | Experimental | Other: DECLARAN creamPatients will apply of DECLARAN cream is the investigational product based on NAC and urea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DECLARAN creamPatients 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. | Other | DECLARAN cream |
Primary outcome
To evaluate the role of NAC plus urea-based cream (DECLARAN) in the prevention of Capecitabine-induced HFS in patient affected by breast cancer.
Time frame: up to 2 years
Cumulative incidence of any grade HFS (according CTCAE vs 5.0,)
5 secondary outcomes
To evaluate severe HFS
Time frame: up to 2 years
To evaluate the impact of HFS on patients' quality of life at 6 weeks
Time frame: up to 2 years
To evaluate the impact of HFS on patients' quality of life at 12 weeks
Time frame: up to 2 years
To evaluate the impact of HFS on patients' quality of life at 24 weeks
Time frame: up to 2 years
To evaluate the safety of NAC plus urea-based cream
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Spazzapan, MD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
Camilla Lisanti, MD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DECLARAN cream in people with Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Spazzapan, MD (+39 0434 659725, spazzapan@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the role of NAC plus urea-based cream (DECLARAN) in the prevention of Capecitabine-induced HFS in patient affected by breast cancer. (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.