NCT01611155

Venlafaxine in Preventing Chronic Oxaliplatin-Induced Neuropathy In Patients Receiving Combination Chemotherapy

A Pilot Randomized, Placebo-controlled, Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or 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.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	venlafaxine	Given PO
DRUG	placebo	Given PO
OTHER	questionnaire administration	Ancillary studies
OTHER	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2012-02-17
• Primary completion: 2014-03-07
• Completion: 2015-09-23
• First posted: 2012-06-04
• Last updated: 2019-09-26
• Results posted: 2019-09-26

Locations

1 site across 1 country: United States