Annals of Oncology Advance Access originally published online on March 16, 2007
Annals of Oncology 2007 18(6):1080-1084; doi:10.1093/annonc/mdm082
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© 2007 European Society for Medical Oncology
hematologic malignancies |
Normal hospital and low-bacterial diet in patients with cytopenia after intensive chemotherapy for hematological malignancy: a study of safety
1 Maastricht Infection Center, Department of Medical Microbiology
2 Department of Internal Medicine
3 Department of Dietetics
4 Department of Clinical Epidemiology and Medical Technology Assessment, University; Hospital Maastricht, Maastricht, the Netherlands
* Correspondence to: Dr F. H. van Tiel, Medical Microbiology, University Hospital Maastricht, PO Box 5800, 6202 AZ Maastricht, The Netherlands. Tel: +31-43-3874644; Fax: +31-43-3876643; E-mail: fvt{at}lmib.azm.nl
Background: The purpose of this randomized, controlled pilot study is to address the question whether normal hospital diet (NHD) is safe when compared with low-bacterial diet (LBD) given to prevent infections in cytopenic patients who receive antimicrobial prophylaxis (AP).
Patients and methods: The patients were randomized into two groups: one group to receive AP and LBD, the other to receive the same AP and NHD. The primary outcome parameter is colonization of the digestive tract with aerobic gram-negative bacilli and yeasts. Secondary outcome parameters were infections and total societal costs.
Results: No statistically significant differences between treatment groups were observed regarding the primary outcome parameter, gut colonization by yeasts or gram-negative bacilli, or infections, use of antimicrobials, days with fever and total societal costs.
Conclusion: On the basis of the results of this pilot study, NHD appears to be as safe as LBD in patients with chemotherapy-induced cytopenia. Furthermore, the results indicate that LBD may offer no additional benefit as an infection preventive measure to the measures already implemented, such as AP. Thus, a larger randomized study, powered adequately to determine noninferiority of NHD to LBD is warranted and safe to be carried out.
Key words: chemotherapy, cytopenia, diet, hematological malignancy, infection prevention, protective isolation
The authors hereby declare that this work is original and had not been published in anther journal, nor is submitted for publication to another journal. Data from this study have been presented as poster and published as an abstract: 1. Harbers MM, Schouten HC, van Boxtel HTC et al. 2003. Low bacterial diet in patients with cytopenia after intensive chemotherapy for hematological malignancy: a study of efficacy. In Abstracts of the 43rd ICAAC, Chicago 2003; 380 (Abstr K-1372).
2. Schouten HC, Harbers MM, Terporten PHW et al. Role of low-bacterial diet (LBD) in infection prevention in acute leukemia patients with chemotherapy induced cytopenia receiving antibiotic prophylaxis (AP). Blood 2003; 102 (11): 233B–234B (Abstr 4657) Part 2.
Present address: Centre for Public Health Forecasting, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.
Present address: Clinical Trial Center Maastricht, University Hospital Maastricht, Maastricht, The Netherlands.
Received for publication December 15, 2006. Accepted for publication February 2, 2007.
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