Shinde, S.S., Seisler, D., Soori, G., Atherton, P.J., Pachman, D.R., Lafky, J., . . . Loprinzi, C.L. (2016). Can pregabalin prevent paclitaxel-associated neuropathy? An ACCRU pilot trial. Supportive Care in Cancer, 24, 547–553. 

To investigate the potential role of pregabalin in the prevention of chemotherapy-induced neuropathy

Patients were randomized to receive placebo or pregabalin 75 mg twice daily starting on the first night of chemotherapy and throughout 12 weeks of chemotherapy. In week 13, the dose was reduced to once daily at bedtime. Patients were instructed to use acetaminophen or oxycodone as needed for breakthrough pain. For the first six days, pain severity and analgesic use were obtained daily; on day 8, they were obtained prior to each subsequent paclitaxel treatment; and they were obtained for six months 30 days after the completion of paclitaxel treatment.

• N = 41 
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving adjuvant or neoadjuvant paclitaxel 
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with a history of peripheral neuropathy, prior exposure to neurotoxic chemotherapy, or diabetes were excluded.

• SITE: Multi-site  
• SETTING TYPE: Outpatient
• LOCATION: New York

PHASE OF CARE: Active antitumor treatment

Double-blind, placebo-controlled trial

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLC)-CIPN20 
• Common Terminology Criteria for Adverse Events (CTCAE), version 4.0

No differences existed between groups in worst, average, or least pain scores, or in analgesic use. No differences existed in the motor neuropathy or autonomic neuropathy subscale scores of the EORTC instrument. No significant differences were observed in adverse events.

The findings did not support any effect of pregabalin for the prevention of chemotherapy-induced neuropathic symptoms.

• Small sample (< 100)
• The doses of pregabalin used here may have been insufficient to show an effect.

Professional guidelines have suggested that gabapentinoids may be considered as an option to treat chemotherapy-induced neuropathy, although their effectiveness has not been established. This study provides limited evidence to suggest that pregabalin, a type of gabapentinoid, is effective for the prevention or reduction of paclitaxel-induced neuropathic symptoms. Given these results, it may not effectively treat established neuropathic symptoms. Currently, limited treatment options exist for the prevention or management of chemotherapy-induced peripheral neuropathy. Nurses need to be aware of chemotherapy agents that have neurotoxic effects, and monitor patients for early detection of such effects to identify the need for potential treatment dose modification.