A Pilot Randomized, Placebo-controlled, Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy
I. To explore whether venlafaxine can prevent or ameliorate chronic, cumulative
neurotoxicity associated with oxaliplatin in cancer patients receiving oxaliplatin,
fluorouracil, leucovorin calcium (FOLFOX).
I. To explore whether venlafaxine can ameliorate acute neuropathy associated with
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Chronic, cumulative neurotoxicity associated with oxaliplatin during the treatment course as measured by the sensory subscale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20
The EORTC QLQ-CIPN20 sensory neuropathy score will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation. Linear mixed models or GEE modeling will be applied, whichever is applicable, based upon available data. The 95% confidence intervals will be constructed for the mean difference in sensory neuropathy score between arms.
United States: Food and Drug Administration
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