Sanchez-Lara, K., Turcott, J.G., Juarez-Hernandez, E., Nunez-Valencia, C., Villanueva, G., Guevara, P., . . . Arrieta, O. (2014). Effects of an oral nutritional supplement containing eicosapentaenoic acid on nutritional and clinical outcomes in patients with advanced non-small cell lung cancer: Randomised trial. Clinical Nutrition, 33, 1017–1023.

DOI Link

Study Purpose

To determine if a nutritional supplement taken by patients with advanced non-small cell lung cancer receiving paclitaxel with cisplantin/carboplatin chemotherapy can improve body composition, fatigue, health-related quality of life (HRQOL), and overall survival.

Intervention Characteristics/Basic Study Process

The patients were randomized to isocaloric diet or isocaloric diet plus eicosapentaenoic-acid (EPA) supplement ProSure®.  Evaluations were conducted at baseline, after the first chemotherapy cycle, and after the second chemotherapy cycle.

Sample Characteristics

  • N = 92  
  • AGE: 44-72 years
  • MALES: control group 23 (50%), intervention group 20 (43.5%); FEMALES: control group 23 (50%), intervention group 26 (56.5%)
  • KEY DISEASE CHARACTERISTICS: Stage IIIb and IV non-small cell lung cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Life expectancy greater than 12 weeks. All patients receiving chemotherapy with paclitaxel and cisplatin or carboplatin every three weeks for two cycles.

Setting

  • SITE: Single site    
  • SETTING TYPE: Other    
  • LOCATION: Mexico

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • Subject Global Assessment (SGA)
  • Bodystat Quadscan 4000 multifrequency
  • Food frequency questionnaire (FFQ)
  • Supplement intake diaries
  • Biochemical analysis
  • EORTC Quality of Life Core 30 Questionnaire (EORTC-QLQ-C30)
  • EORTC QLQ-LC13
  • Common Terminology Criteria for Adverse Events (CATCAE)

Results

The ONS-EPA group exhibited significant differences in weight (p = 0.01) and lean body mass (p = 0.01). Significant improvement was also seen in calorie and protein intake (p <  0.001) when the nutritional supplement was included. The ONS-EPA group also exhibited significant improvement in inflammatory markers between time points (p = 0.02 to p = 0.05). In HRQOL, there was significant improvement in global health status between time points for the ONS-EPA group (p = 0.021). Differences were seen between groups in fatigue (p = 0.04), appetite loss (p = 0.05), and neuropathy (p = 0.05)

Conclusions

In this study, ONS-EPA supplementation appears to be effective in improving nutritional status and decreasing side effects (appetite loss) in patients receiving chemotherapy for non-small cell lung cancer.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Subject withdrawals of 10% or greater 
  • Only patients with non-small cell lung cancer were included.
  • There was a high rate of attrition in the control group (6 of 46) due to disease trajectory (worsening condition and death)

Nursing Implications

More studies need to be done with EPA supplementation in this and other cancers.