Zhang, R.X., Wu, X.J., Wan, D.S., Lu, Z.H., Kong, L.H., Pan, Z.Z., & Chen, G. (2012). Celecoxib can prevent capecitabine-related hand-foot syndrome in stage II and III colorectal cancer patients: Result of a single-center, prospective randomized phase III trial. Annals of Oncology, 23, 1348–1353.

To compare the incidence and severity of hand-foot syndrome (HFS) in patients who received capecitabine with and without celecoxib.

Patients were randomized to receive oral celecoxib 200 mg BID or no intervention. Sampling was stratified based on the specific chemotherapy regimen used. Patients were educated on how to prevent side effects of therapy and monitored weekly with telephone calls and monthly clinic visits.

• The study reported on a sample of 139 patients with colorectal cancer.
• Mean patient age was 58 years.
• The sample was 60% male and 40% female.
• Some patients received oxaliplatin as well as capecitabine.

• Single site
• Outpatient
• China

Patients were undergoing the active antitumor treatment phase of care.

This was a randomized, prospective trial.

National Cancer Institute (NCI) common toxicity criteria (CTC), version 4

• The incidence of grade 1 to 2 HFS was lower in the celecoxib group (p < 0.05).
• The mean number of chemotherapy cycles before development of HFS was 4.336 in the celecoxib group versus 5.852 in the control group (p < 0.001).
• No adverse events were associated with use of celecoxib.

Celecoxib as used in this trial may delay the onset and severity of HFS in patients receiving capecitabine-based chemotherapy. In addition, celecoxib was not associated with adverse events.

• No subgroup analysis was conducted between patients who received the two different chemotherapy regimens included; therefore, whether those differences would have affected results is unclear.
• The timeframe and sample characteristics of this study were similar to those of another publication from this group that stated a different sample size and method of HFS rating. Whether this study incorporated the same group of patients is unclear.
• Risk of bias existed in the study design because of the lack of blinding and an appropriate attentional control condition.

Use of anti-inflammatory medications such as celecoxib may help delay the onset and severity of HFS in patients receiving capecitabine-based chemotherapy. In addition, no adverse events were reported with use as long as six months.