PEP Topic 
Chemotherapy-Induced Diarrhea

Budesonide is used in treating Crohn's disease. It is a corticosteroid that decreases inflammation in the digestive tract of people who have Crohn’s disease to reduce inflammation and associated diarrhea. Budesonide is available as a capsule to take by mouth. It has been examined for its effect in treating chemotherapy-associated diarrhea.

Effectiveness Not Established

Research Evidence Summaries

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.

doi: 10.1159/000086971

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

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

Study Design:

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

Measurement Instruments/Methods:

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.

Nursing Implications:

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.