Clinical Trials

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.

OBJECTIVES:

     I. To record the types of patients that we treat, along with the reported efficacy and potential toxicity associated with scrambler therapy.

     II. To get experience with patient reported outcome measurement tools that we use in this trial, including a report of analgesic use.

     OUTLINE:    Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity.    After completion of study treatment, patients are followed up for 10 weeks.

     III. To explore neurologic testing changes in patients receiving scrambler therapy.