Budesonide

Budesonide

PEP Topic 
Chemotherapy-Induced Diarrhea
Description 

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
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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.

Results:

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).

Conclusions:

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.

Limitations:

  • 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.

Nieuweboer, A.J., de Graan, A.M., Hamberg, P., Bins, S., van Soest, R.J., van Alphen, R.J., . . . Mathijssen, R.H. (2016). Effects of budesonide on cabazitaxel pharmacokinetics and cabazitaxel-induced diarrhea: A randomized, open-label multicenter phase II study. Clinical Cancer Research. Advance online publication. 

doi: 10.1158/1078-0432.CCR-16-2110
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Study Purpose:

To evaluate the effects of budesonide on cabazitaxel-induced diarrhea during two treatment cycles

Intervention Characteristics/Basic Study Process:

Patients were randomized to receiver cabazitaxel plus prednisone or cabazitaxel plus prednisone with 9 mg budesonidedaily for 44 days. Budesonide was given for the first two courses and was begun two days before chemotherapy administration. Loperamide was used for diarrhea.

Sample Characteristics:

  • N = 227   
  • MEDIAN AGE = 68 years
  • AGE RANGE = 49–85 years
  • MALES: 100%  
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Ninety-one percent had prior chemotherapy, and 52% had prior radiation therapy.

Setting:

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Netherlands

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Study Design:

  • Randomized, open-label, phase II trial

Measurement Instruments/Methods:

  • Common Terminology Criteria for Adverse Events (CTCAE)

Results:

Among those receiving budesonide, 18% had grade 2 or 3 diarrhea, compared to 12% in the comparison group. Seven patients were hospitalized for diarrhea during treatment. No difference in diarrhea grade or prevalence existed between study groups.

Conclusions:

Budesonide had no significant effect on the incidence or severity of diarrhea.

Limitations:

  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Use of loperamide was not reported

Nursing Implications:

Budesonide was not shown to be effective to reduce the prevalence or severity of diarrhea among patients receiving cabazitaxel.

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