Xiao, Y., Liu, J., Huang, X. E., Ca, L.H., Ma, Y.M., Wei, W., . . . Wu, Y.J. (2014). Clinical study on fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain. Asian Pacific Journal of Cancer Prevention, 15, 10445–10449.

Study Purpose

To assess the safety and efficacy of fluvoxamine combined with prolonged-release oxycodone for the management of cancer-related chronic pain

Intervention Characteristics/Basic Study Process

Patients with moderate to severe cancer-related pain were randomized to either the control group, which was treated with only prolonged-release oxycodone, or the prolonged-release oxycodone combined with fluvoxamine group. A daily maintenance dose of oxycodone was determined per patient after two weeks. Fluvoxamine began at 50 mg per day and increased by 50–100 mg per day to a maximum of 150 mg twice daily. Patients were assessed three times daily for pain response and dosage adjustment.

Sample Characteristics

  • N = 120
  • AGE = Not provided
  • MALES: Not provided, FEMALES: Not provided
  • KEY DISEASE CHARACTERISTICS: Not provided
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients had a life expectancy of at least two months at study entry.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: China

Study Design

Randomized, open-label trial

Measurement Instruments/Methods

  • Numeric Rating Scale (NRS)
  • Opioid consumption

Results

Pain severity declined in both groups. There were no reported significant differences between groups for pain severity or opioid consumption.

Conclusions

The findings of this study did not demonstrate the efficacy of fluvoxamine for chronic pain management.

Limitations

  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The timing of measurement and duration were not well described. Although pain was measured every three hours, the exact measure used in the analysis was not stated. There was no information about the duration of the study, total opioid dosages in both groups before and after the intervention, or demographic information. The sample numbers differed between the tables and the body of the article, calling into question the overall validity of the results.

Nursing Implications

This study did not show any benefit from the addition of fluvoxamine to prolonged-release opioids in the management of moderate to severe chronic cancer-related pain.