Hata, T., Honda, M., Kobayashi, M., Toyokawa, A., Tsuda, M., Tokunaga, Y., . . . Mishima, H. (2015). Effect of pH adjustment by mixing steroid for venous pain in colorectal cancer patients receiving oxaliplatin through peripheral vein: A multicenter randomized phase II study (APOLLO). Cancer Chemotherapy and Pharmacology, 76, 1209–1215. 

DOI Link

Study Purpose

To evaluate whether mixing dexamethasone with an oxaliplatin intravenous infusion can reduce venous pain associated with the infusion

Intervention Characteristics/Basic Study Process

Patients receiving either ​capecitabine and oxaliplatin (CapeOX) or S-1 plus oxaliplatin (SOX) chemotherapy were randomly assigned to the experimental or control groups. In the experimental group, 1.65 mg of dexamethasone was mixed with a 5% glucose solution in which 130 mg/m2 was dissolved. The resulting mixture was infused over two hours. Those in the control group received the same infusion without the addition of dexamethasone. Patients were evaluated over four treatment cycles.

Sample Characteristics

  • N = 48
  • MEAN AGE = 66 years (range = 46–81 years)
  • MALES: 79%, FEMALES: 21%
  • KEY DISEASE CHARACTERISTICS: All patients had colorectal cancers and were receiving regimens containing oxaliplatin.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Verbal Rating Scale (VRS) for pain
  • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Results

The incidence of grade 2 or greater venous pain based on the CTCAE was 33.3% in patients receiving steroids and 56% in those who did not (based on only 22 patients). The relative risk of venous pain was 0.60 (95% CI, 0.31–1.16).

Conclusions

Patients who received dexamethasone with oxaliplatin tended to experience less venous pain.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The study was slightly underpowered.

Nursing Implications

In this study, the incidence of severe venous pain during oxaliplatin infusion was lower with the addition of dexamethasone to the infusion. It has been suggested that mixing dexamethasone may be an option for patients with venous pain or phlebitis caused by chemotherapy. Additional research confirming the efficacy of this approach is needed.