Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400849
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-09
Brief Title:
Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy
Sponsor:
Centre Antoine Lacassagne
Organization:
Centre Antoine Lacassagne
Study Overview
Official Title:
Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing the Development of Paclitaxel-induced Peripheral Neuropathy in Non-metastatic Breast Cancer A Prospective Single-centre Self-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
ARIANE
Brief Summary:
Breast cancer is the most frequently diagnosed cancer in the world In France 58000 new cases were detected in 2018 Breast cancer is therefore the most common cancer in women The 5-year survival rate for all stages combined is 88 These excellent survival figures have been achieved thanks to improvements in treatment including the advent of chemotherapy The majority of patients will be cured of their cancer so post-cancer quality of life is a major issue hence the importance of trying to reduce long-term sequelae
Taxanes are one of the main cytotoxic anticancer agents used in the treatment of breast cancer However taxanes have a direct effect on the central and peripheral nervous systems and can induce chemotherapy-induced peripheral neuropathy CIPN The mechanisms of NPIC by taxanes are not fully understood CINP is manifested by symptoms of paresthesia numbness burning pain altered temperature perception myalgia myopathy fine motor difficulties gait and balance disturbances muscle weakness in the lower limbs andor functional decline
NPIC occurs in 80 to 97 of patients treated with taxanes and is the main limiting toxicity during paclitaxel administration NPIC often leads to postponement or reduction of dose or even discontinuation of treatment In addition NPIC may last for several months or even years after the end of anti-cancer chemotherapy and represents the main long-term sequelae This can promote andor exacerbate symptoms of psychological distress depressive symptoms and symptoms of anxiety and lead to a reduction in quality of life QoL Prevention of NIPC is therefore a major issue in breast cancer treatment According to the 2014 guidelines from the American Society of Clinical Oncology prevention and treatment of IPN are inadequate with current weapons and there is an urgent need to evaluate and find new methods of prevention One of the challenges in the management of NIPC will be to reduce the pain induced without diminishing the anti-tumour effect of anti-cancer agents
In recent years the effectiveness of cryotherapy using a frozen glove and compression therapy using surgical gloves SG in preventing taxane-induced PINC has been reported During chemotherapy patients wore a frozen glove on one hand and two surgical gloves of the same size on the other hand continuously Recent study explained how compression therapy and cryotherapy shared a similar mechanism of reducing drug exposure due to vasoconstriction during paclitaxel infusion The low temperature associated with cryotherapy would reduce paclitaxel uptake and peripheral nerve damage or mechanotransduction and allow a reduction in NIPC
To date no study has investigated the efficacy of combining the two means of prevention The current standard at the Centre Antoine Lacassagne is cryotherapy The aim of this prospective self-controlled trial is therefore to compare the efficacy of cryotherapy combined with compression prevention versus cryotherapy alone in preventing paclitaxel-induced peripheral neuropathy in patients undergoing adjuvant treatment for localised breast cancer
Taxanes are one of the main cytotoxic anticancer agents used in the treatment of breast cancer However taxanes have a direct effect on the central and peripheral nervous systems and can induce chemotherapy-induced peripheral neuropathy CIPN The mechanisms of NPIC by taxanes are not fully understood CINP is manifested by symptoms of paresthesia numbness burning pain altered temperature perception myalgia myopathy fine motor difficulties gait and balance disturbances muscle weakness in the lower limbs andor functional decline
NPIC occurs in 80 to 97 of patients treated with taxanes and is the main limiting toxicity during paclitaxel administration NPIC often leads to postponement or reduction of dose or even discontinuation of treatment In addition NPIC may last for several months or even years after the end of anti-cancer chemotherapy and represents the main long-term sequelae This can promote andor exacerbate symptoms of psychological distress depressive symptoms and symptoms of anxiety and lead to a reduction in quality of life QoL Prevention of NIPC is therefore a major issue in breast cancer treatment According to the 2014 guidelines from the American Society of Clinical Oncology prevention and treatment of IPN are inadequate with current weapons and there is an urgent need to evaluate and find new methods of prevention One of the challenges in the management of NIPC will be to reduce the pain induced without diminishing the anti-tumour effect of anti-cancer agents
In recent years the effectiveness of cryotherapy using a frozen glove and compression therapy using surgical gloves SG in preventing taxane-induced PINC has been reported During chemotherapy patients wore a frozen glove on one hand and two surgical gloves of the same size on the other hand continuously Recent study explained how compression therapy and cryotherapy shared a similar mechanism of reducing drug exposure due to vasoconstriction during paclitaxel infusion The low temperature associated with cryotherapy would reduce paclitaxel uptake and peripheral nerve damage or mechanotransduction and allow a reduction in NIPC
To date no study has investigated the efficacy of combining the two means of prevention The current standard at the Centre Antoine Lacassagne is cryotherapy The aim of this prospective self-controlled trial is therefore to compare the efficacy of cryotherapy combined with compression prevention versus cryotherapy alone in preventing paclitaxel-induced peripheral neuropathy in patients undergoing adjuvant treatment for localised breast cancer
Detailed Description:
None
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