Zimmerman, C., Atherton, P.J., Pachman, D., Seisler, D., Wagner-Johnston, N., Dakhil, S., . . . Loprinzi, C.L. (2016). MC11C4: A pilot randomized, placebo-controlled, double-blind study of venlafaxine to prevent oxaliplatin-induced neuropathy. Supportive Care in Cancer, 24, 1071–1078.

To obtain data to support conducting a phase III trial of venlafaxine to prevent oxaliplatin-induced neurotoxicity

Patients were stratified according to planned calcium and magnesium administration, cancer stage, and treatment cycle, then randomized to receive venlafaxine extended release 37.5 mg versus placebo twice daily. The study treatment was begun on the evening of the first or second chemotherapy treatment and continued for one week following completion of the FOLFOX treatment. Assessments were taken at baseline, prior to each FOLFOX treatment, and at 1, 3, 6, and 12 months postcompletion.

• N = 43
• MEAN AGE = 61.3 years
• MALES: 52%, FEMALES: 48%

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: USA

PHASE OF CARE: Active antitumor treatment

Randomized, double-blind, placebo-controlled trial

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)-CIPN20 symptom questionnaire
• Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
• Oxaliplatin Acute Symptom Questionnaire

No significant differences in any measures of neuropathy outcomes existed between groups.

Venlafaxine did not reduce neuropathic toxicities associated with oxaliplatin.

Small sample (< 100)

Data from this trial do not support the use of venlafaxine for the prevention of neuropathic symptoms associated with oxaliplatin. Ongoing research is needed to identify effective interventions for this treatment complication.