Ignite Creation Date:
2024-05-06 @ 12:37 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01611155
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2012-05-31
Brief Title:
Venlafaxine in Preventing Chronic Oxaliplatin-Induced Neuropathy In Patients Receiving Combination Chemotherapy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Pilot Randomized Placebo-controlled Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy
Status:
COMPLETED
Status Verified Date:
2018-10
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:
You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care Oxaliplatin commonly causes neuropathy numbing tingling andor painThe purpose of this study is to compare the effects good andor bad of venlafaxine with a placebo an inactive agent on oxaliplatin-induced neuropathy numbing tingling andor pain
Detailed Description:
PRIMARY OBJECTIVES
I To explore whether venlafaxine can prevent or ameliorate chronic cumulative neurotoxicity associated with oxaliplatin in cancer patients receiving oxaliplatin fluorouracil leucovorin calcium FOLFOX
SECONDARY OBJECTIVES
I To explore whether venlafaxine can ameliorate acute neuropathy associated with oxaliplatin
TERTIARY OBJECTIVES
I To explore whether venlafaxine can increase the cumulative oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity
II To explore whether venlafaxine causes adverse events in this setting III To explore whether the neuropathy data provided by the Rydel-Seiffer graduated tuning fork is consistent with patient-reported outcome PRO measures of chemotherapy-induced peripheral neuropathy CIPN and whether this tool might cause different results in patients receiving venlafaxine versus placebo
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive venlafaxine orally PO twice daily BID beginning on day 1 of and continuing through completion of FOLFOX
ARM II Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX
After completion of study treatment patients are followed up at 1 3 6 12 and 18 months
I To explore whether venlafaxine can prevent or ameliorate chronic cumulative neurotoxicity associated with oxaliplatin in cancer patients receiving oxaliplatin fluorouracil leucovorin calcium FOLFOX
SECONDARY OBJECTIVES
I To explore whether venlafaxine can ameliorate acute neuropathy associated with oxaliplatin
TERTIARY OBJECTIVES
I To explore whether venlafaxine can increase the cumulative oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity
II To explore whether venlafaxine causes adverse events in this setting III To explore whether the neuropathy data provided by the Rydel-Seiffer graduated tuning fork is consistent with patient-reported outcome PRO measures of chemotherapy-induced peripheral neuropathy CIPN and whether this tool might cause different results in patients receiving venlafaxine versus placebo
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive venlafaxine orally PO twice daily BID beginning on day 1 of and continuing through completion of FOLFOX
ARM II Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX
After completion of study treatment patients are followed up at 1 3 6 12 and 18 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-00318 | REGISTRY | CTRP Clinical Trial Reporting Program | None |