Karthaus, M., Ballo, H., Abenhardt, W., Steinmetz, T., Geer, T., Schimke, J., … Kleeberg, U. (2005). Prospective, double-blind, placebo-controlled, multicenter, randomized phase III study with orally administered budesonide for prevention of irinotecan (CPT-11)-induced diarrhea in patients with advanced colorectal cancer. Oncology, 68(4–6), 326–332.

Participants were randomly assigned to receive either 3 mg oral budesonide three times per day for a total of eight weeks during two cycles of irinotecan or a placebo. Rescue medication was given at an initial dosage of 4 mg loperamide followed by 2 mg every two hours until free of diarrhea for 12 hours.

The study reported on 56 patients with advanced colorectal cancer receiving 125 mg/m² irinotecan once per week.

This was a prospective, double-blind, placebo-controlled, multicenter, randomized phase III trial for prevention of diarrhea.

Patients recorded presence of diarrhea (defined as more than four stools per day), duration of diarrhea, and use of loperamide in patient diaries.

Diarrhea could be prevented in 58.3% of the budesonide-treated patients compared to 38.5% of the patients receiving the placebo (p = 0.257).

Budesonide provided superior prevention of diarrhea compared to placebo in the first cycle. However, the trial failed to show that budesonide provided a statistically significant benefit in preventing irinotecan-induced diarrhea.

• The sample size was small.
• Therapeutic administration might be more efficacious than prophylactic administration.

In a previous study (Lenfers, 1999), budesonide was found to be effective in treatment chemotherapy-induced diarrhea in patients who had treatment failure with loperamide. Budesonide also has been proposed as a therapeutic approach for inflamed bowel. However, this study did not support that finding. Further research is warranted.