Ignite Creation Date:
2025-12-18 @ 9:44 AM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT05695313
Status:
None
Last Update Posted:
2024-04-22 00:00:00
First Post:
2023-01-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
Sponsor:
None
Organization:
Study Overview
Official Title:
Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
Status:
None
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:
NEUROTAX
Brief Summary:
This study recommends the use of OnLife dietary supplement which will be followed by a few day before the initiation of PACLITAXEL for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy. This would limit the number of PACLITAXEL dose reductions and premature interruptions of this cehemotherapy, thus potentially improving the results in terms of antitumor efficacy while improving the quality of life of patients treated with weekly PACLITAXEL.
Two treatment arms :
\- ARM A : 20 patients included in the placebo arm (Standard chemotherapy with PACLITAXEL + placebo dietary supplement) ARM B : 40 patients included in the experimental arm (standard PACLITAXEL chemotherapy + OnLife® food supplement)
Two treatment arms :
\- ARM A : 20 patients included in the placebo arm (Standard chemotherapy with PACLITAXEL + placebo dietary supplement) ARM B : 40 patients included in the experimental arm (standard PACLITAXEL chemotherapy + OnLife® food supplement)
Detailed Description:
None
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?: