Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627348
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-10-20
Brief Title:
Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy - a Unicentric Prospective-controlled Randomized Clinical Trial for Comparison of Local Hilotherapy Vs No Therapy to Prevent Peripheral Polyneuropathy During Taxan-based Chemotherapy Regimen
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:
HiPPo
Brief Summary:
Prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by Taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women
Detailed Description:
In this trial patients receiving Taxan-based chemotherapy regimen eg paclitaxel nab-paclitaxel or docetaxel in gynecological malignancies such as ovarian cnacer breast cancer endometrial cancer or cervical cancer will either receive cooling of hands and feet during the application of above-mentioned substances or not The cooling will be provided by a machine called Hilotherm ChemoCare unit and will be administered constantly at a temperature of 15-17C Randomization will be 5050
if a patient is randomized in the non-interventional arm no cooling is allowed during the application of the chemotherapy
To assess the occurance and the extent of peripheral neuropathy a neurological examination will take place before the start of chemotherapy in the middle of the planned cycles of chemotherapy and after the completion of the regimen
Quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires
if a patient is randomized in the non-interventional arm no cooling is allowed during the application of the chemotherapy
To assess the occurance and the extent of peripheral neuropathy a neurological examination will take place before the start of chemotherapy in the middle of the planned cycles of chemotherapy and after the completion of the regimen
Quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires
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