Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639178
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAND-TO-HAND
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 limitingMoreover 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
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 limitingMoreover 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 limitingMoreover 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
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 limitingMoreover 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None