Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422949
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-15
Brief Title:
Efficacy and Safety of HILOTERM Device for the Prevention of Peripheral Neuropathy
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
A Study on the Efficacy and Safety of HILOTERM Device for the Prevention of Chemotherapy-induced Peripheral Neuropathy in Early Breast Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Taxol is a very effective drug in breast cancer but it can cause peripheral neuropathy PN This toxicity is often dose-limiting Symptoms of PN usually improve after taxol discontinuation but 80 of affected women experience symptoms 1-3 years after treatment stop The intensity the duration and the type of symptoms related to PN are very different and they can strongly interfere with patients quality of life
The application of cold to the hands and feet seems to be able to reduce the incidence of PN Hilotherm is a machine that allows to cool hands and feet The aim of this study is to verify whether the use of Hilotherm is able to reduce the incidence of moderate and severe PN and to evaluate the tolerability of Hilotherm and its impact on quality of life
The application of cold to the hands and feet seems to be able to reduce the incidence of PN Hilotherm is a machine that allows to cool hands and feet The aim of this study is to verify whether the use of Hilotherm is able to reduce the incidence of moderate and severe PN and to evaluate the tolerability of Hilotherm and its impact on quality of life
Detailed Description:
Taxol is a very effective drug in breast cancer but it can cause peripheral neuropathy PN that is damage to the nerves of the hands and feet This toxicity can begin a few days to months after starting taxol treatment and is often dose-limiting
Symptoms of chemotherapy-induced peripheral neuropathy CIPN usually improve after taxol discontinuation but 80 of affected women experience symptoms 1-3 years after treatment stop The intensity the duration and the type of symptoms related to PN are very different and they range from mild and transient symptoms to more severe and persistent symptoms These symptoms can strongly interfere with patients quality of life and can create difficulties in carrying out activities of daily living
Despite numerous pharmacological approaches no substance has proven capable of counteracting the onset of PN in patients eligible to receive chemotherapy with taxol Some clinical studies have shown that the application of cold to the hands and feet is able to reduce the incidence of PN because the cold-induced constriction of the vessels leads to a reduction of blood flow and consequently to a reduced inflow of drug at the level of the hands and feet
Hilotherm is a machine that allows to keep hands and feet at a constant temperature of 10C The aim of this study is to verify whether the use of Hilotherm is able to reduce the incidence of moderate and severe PN and to evaluate the tolerability of Hilotherm and its impact on quality of life
Symptoms of chemotherapy-induced peripheral neuropathy CIPN usually improve after taxol discontinuation but 80 of affected women experience symptoms 1-3 years after treatment stop The intensity the duration and the type of symptoms related to PN are very different and they range from mild and transient symptoms to more severe and persistent symptoms These symptoms can strongly interfere with patients quality of life and can create difficulties in carrying out activities of daily living
Despite numerous pharmacological approaches no substance has proven capable of counteracting the onset of PN in patients eligible to receive chemotherapy with taxol Some clinical studies have shown that the application of cold to the hands and feet is able to reduce the incidence of PN because the cold-induced constriction of the vessels leads to a reduction of blood flow and consequently to a reduced inflow of drug at the level of the hands and feet
Hilotherm is a machine that allows to keep hands and feet at a constant temperature of 10C The aim of this study is to verify whether the use of Hilotherm is able to reduce the incidence of moderate and severe PN and to evaluate the tolerability of Hilotherm and its impact on quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None