de Andrade, D.C., Jacobsen Teixeira, M., Galhardoni, R., Ferreira, K.S.L., Braz Mileno, P., Scisci, N., . . . de Souza, A.M. (2017). Pregabalin for the prevention of oxaliplatin-induced painful neuropathy: A randomized, double-blind trial. Oncologist, 22, 1154–1155, e99–e105.

DOI Link

Study Purpose

Evaluate the effect on pregabalin given three days prior and three days after each oxaliplatin dose on oxaliplatin-induced peripheral neuropathy

Intervention Characteristics/Basic Study Process

Pregabalin versus placebo given three days prior to and three days after oxaliplatin infusion on weeks 1, 3, and 5 of an 8-week cycle.

Sample Characteristics

  • N = 199 enrolled, 143 in the final analysis (56 participants did not receive at least one full cycle of FOLFOX 
  • AGE: Median = 57 years (mean = 57.13, SD = 10.51)
  • MALES: 99 patients (49.7%)  
  • FEMALES: 100 (50.3%)
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: CRC, newly diagnosed stage III/IV
  • OTHER KEY SAMPLE CHARACTERISTICS: Dose of pregabalin was 150-600 mg daily; placebo was also 150-600 mg daily with drug 1 and 150 mg  dose for drug 2.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Multiple sites; Sao Paulo, Brazil

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Randomized, placebo controlled trial

Measurement Instruments/Methods

Main outcome was pain level based on the visual analog scale (rating 0-10) and the brief pain inventory (BPI). Secondary endpoints  were the presence of pain from neuropathy as well the severity of pain based on the Douleur Neuropathique–4 (DN-4), the short-form McGill Pain Questionnaire (MPQ), the Neuropathic Pain Symptom Inventory (NPSI), and any changes in the nerve conduction studies as well as subjective side effect profile.

Results

The pain intensity level of the pregabalin group was 1.03 (95% CI [0.76, 1.26]) and was 0.85 in the placebo group (95% CI [0.64, 1.06]). Quality-of-life scores did not differ between the two groups (placebo QOL was 76.9 [SD = 23.1] and the pregabalin QOL was 79.4 [SD = 20.6]). There were no significant differences in any of the outcome measures.

Conclusions

The intervention was safe, but did not decrease the pain severity or incidence of oxaliplatin-induced peripheral neuropathy.

Limitations

  • Findings not generalizable
  • Other limitations/explanation: Only relevant to oxaliplatin

Nursing Implications

Pregabalin may be safe to take, but does not prevent neuropathy in those receiving oxaliplatin.