Prevention of irinotecan induced diarrhea by probiotics: A randomized double blind, placebo controlled pilot study

Complementary Therapies in Medicine

Volumn 23, Issue 3, 2015, Pages 356-362

  Mego, Michal ^a   Chovanec, Jozef ^b   Vochyanova Andrezalova, Iveta ^a   Konkolovsky, Peter ^c   Mikulova, Milada ^d   Reckova, Maria ^c   Miskovska, Vera ^a   Bystricky, Branislav ^e   Beniak, Juraj ^c   Medvecova, Lenka ^c   Lagin, Adela ^f   Svetlovska, Daniela ^a   Spanik, Stanislav ^a   Zajac, Vladimir ^g   Mardiak, Jozef ^a   Drgona, Lubos ^a  

^a Bratislava   (Slovakia)

^b Department of Oncology   (Slovakia)

^c Regional Cancer Center   (Slovakia)

^d St Elisabeth Cancer Institute   (Slovakia)

^e Hospital Trencin   (Slovakia)

^f Faculty of Natural Sciences   (Slovakia)

^g CANCER RESEARCH INSTITUTE   (Slovakia)

Author keywords

Diarrhea; Irinotecan; Prevention; Probiotics

Indexed keywords

ATROPINE PLUS DIPHENOXYLATE; BETA GLUCURONIDASE; BEVACIZUMAB; CAPECITABINE; CETUXIMAB; FLUOROURACIL; IRINOTECAN; LOPERAMIDE; PLACEBO; PROBIOTIC AGENT; CAMPTOTHECIN;

ADULT; AGED; ARTICLE; BIFIDOBACTERIUM BIFIDUM; BIFIDOBACTERIUM BREVE; BIFIDOBACTERIUM INFANTIS; BIFIDOBACTERIUM LONGUM; CLINICAL ARTICLE; COLORECTAL CANCER; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EARLY TERMINATION OF CLINICAL TRIAL; ENTEROCOLITIS; ENZYME INHIBITION; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; INFECTION; LACTOBACILLUS ACIDOPHILUS; LACTOBACILLUS BREVIS; LACTOBACILLUS CASEI; LACTOBACILLUS PLANTARUM; LACTOBACILLUS RHAMNOSUS; MALE; MULTICENTER STUDY; PATIENT SELECTION; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; STREPTOCOCCUS; STREPTOCOCCUS THERMOPILUS; TREATMENT DURATION; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; MIDDLE AGED; VERY ELDERLY;

AGED; AGED, 80 AND OVER; CAMPTOTHECIN; DIARRHEA; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PILOT PROJECTS; PROBIOTICS;

EID: 84937641140     PISSN: 09652299     EISSN: 18736963     Source Type: Journal    
DOI: 10.1016/j.ctim.2015.03.008     Document Type: Article

References (37)

1. Bellm L.A., Epstein J.B., Rose-Ped A., Martin P., Fuchs H.J. Patient reports of complications of bone marrow transplantation. Support Care Cancer 2000, 8:33-39.
2. Blijlevens N.M., Donnelly J.P., De Pauw B.E. Mucosal barrier injury: biology, pathology, clinical counterparts and consequences of intensive treatment for haematological malignancy: an overview. Bone Marrow Transplant 2000, 25:1269-1278.
3. Sonis S.T. The pathobiology of mucositis. Nat Rev Cancer 2004, 4:277-284.
4. van Vliet M.J., Harmsen H.J., de Bont E.S., Tissing W.J. The role of intestinal microbiota in the development and severity of chemotherapy-induced mucositis. PLoS Pathog 2010, 6:e1000879.
5. Mego M., Holec V., Drgona L., Hainova K., Ciernikova S., Zajac V. Probiotic bacteria in cancer patients undergoing chemotherapy and radiation therapy. Complement Ther Med 2013, 21:712-723.
6. Michael M., Brittain M., Nagai J., Feld R., Hedley D., Oza A., et al. Phase II study of activated charcoal to prevent irinotecan-induced diarrhea. J Clin Oncol 2004, 22:4410-4417.
7. Lin X.B., Farhangfar A., Valcheva R., Sawyer M.B., Dieleman L., Schieber A., et al. The role of intestinal microbiota in development of irinotecan toxicity and in toxicity reduction through dietary fibres in rats. PLOS ONE 2014, 9:e83644.
8. Logan R.M., Gibson R.J., Bowen J.M., Stringer A.M., Sonis S.T., Keefe D.M. Characterisation of mucosal changes in the alimentary tract following administration of irinotecan: implications for the pathobiology of mucositis. Cancer Chemother Pharmacol 2008, 62:33-41.
9. Logan R.M., Stringer A.M., Bowen J.M., Gibson R.J., Sonis S.T., Keefe D.M. Serum levels of NFkappaB and pro-inflammatory cytokines following administration of mucotoxic drugs. Cancer Biol Ther 2008, 7:1139-1145.
10. Stringer A.M., Gibson R.J., Bowen J.M., Logan R.M., Ashton K., Yeoh A.S., et al. Irinotecan-induced mucositis manifesting as diarrhoea corresponds with an amended intestinal flora and mucin profile. Int J Exp Pathol 2009, 90:489-499.
11. Stringer A.M., Gibson R.J., Logan R.M., Bowen J.M., Yeoh A.S., Laurence J., et al. Irinotecan-induced mucositis is associated with changes in intestinal mucins. Cancer Chemother Pharmacol 2009, 64:123-132.
12. Sakata Y., Suzuki H., Kamataki T. Preventive effect of TJ-14, a Kampo medicine, on diarrhea induced by irinotecan. Proc Am Soc Clin Oncol 1994, 13:394. [Abstr. 1578].
13. Fuller R. Probiotics in man and animals. J Appl Bacteriol 1989, 66:365-378.
14. Ferencik M., Ebringer L., Mikes Z., Jahnova E., Ciznar I. Beneficial modification of the human intestinal microflora using orally administered lactic acid bacteria. Bratisl Lek Listy 1999, 100:238-245.
15. Goldin B.R. Intestinal microflora: metabolism of drugs and carcinogens. Ann Med 1990, 22:43-48.
16. Lalla R.V., Bowen J., Barasch A., Elting L., Epstein J., Keefe D.M., et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer 2014, 120:1453-1461. Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO).
17. Chow S.C., Shao J., Wang H. Sample size calculations in clinical research 2003, Marcel Dekker, New York.
18. Fleiss J.L., Levin B., Paik M.C. Statistical methods for rates and proportions 2003, John Wiley & Sons, New York. 3rd ed.
19. Bishop J.F., Matthews J.P., Young G.A., Szer J., Gillett A., Joshua D., et al. A randomized study of high-dose cytarabine in induction in acute myeloid leukemia. Blood 1996, 87:1710-1717.
20. Camera A., Andretta C., Villa M.R., Volpicelli M., Picardi M., Rossi M., et al. Intestinal toxicity during induction chemotherapy with cytarabine-based regimens in adult acute myeloid leukemia. Hematol J 2003, 4:346-350.
21. Talbott G.H., Cassileth P.A., Paradiso L., Correa-Coronas R., Bond L. Oral enoxacin for infection prevention in adults with acute nonlymphocytic leukemia. Antimicrob Agents Chemother 1993, 37:474-482.
22. Wiernik P.H., Banks P.L., Case D.C., Arlin Z.A., Periman P.O., Todd M.B., et al. Cytarabine plus idarubicine or daunorubicine as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood 1992, 79:313-319.
23. Mego M., Koncekova R., Mikuskova E., Drgona L., Ebringer L., Demitrovicova L., et al. Prevention of febrile neutropenia in leukemic patients by probiotic strain Enterococcus faecium M-74. Phase II study. Support Care Cancer 2006, 14:285-290.
24. Stringer A.M., Gibson R.J., Logan R.M., Bowen J.M., Yeoh A.S., Burns J., et al. Chemotherapy-induced diarrhea is associated with changes in the luminal environment in the DA rat. Exp Biol Med (Maywood) 2007, 232:96-106.
25. Logan R.M., Stringer A.M., Bowen J.M., Yeoh A.S., Gibson R.J., Sonis S.T., et al. The role of pro-inflammatory cytokines in cancer treatment-induced alimentary tract mucositis: pathobiology, animal models and cytotoxic drugs. Cancer Treat Rev 2007, 33:448-460.
26. Gibson R.J., Bowen J.M., Inglis M.R., Cummins A.G., Keefe D.M. Irinotecan causes severe small intestinal damage, as well as colonic damage, in the rat with implanted breast cancer. J Gastroenterol Hepatol 2003, 18:1095-1100.
27. Gibson R.J., Keefe D.M. Cancer chemotherapy-induced diarrhoea and constipation: mechanisms of damage and prevention strategies. Support Care Cancer 2006, 14:890-900.
28. Yeoh A.S., Bowen J.M., Gibson R.J., Keefe D.M. Nuclear factor kappaB (NFkappaB) and cyclooxygenase-2 (cox-2) expression in the irradiated colorectum is associated with subsequent histopathological changes. Int J Radiat Oncol Biol Phys 2005, 63:1295-1303.
29. Stringer A.M. Interaction between host cells and microbes in chemotherapy-induced mucositis. Nutrients 2013, 5:1488-1499.
30. Edlund C., Nord C.E. Effect on the human normal microflora of oral antibiotics for treatment of urinary tract infections. J Antimicrob Chemother 2000, 46(Suppl. 1):41-48.
31. van Vliet M.J., Tissing W.J., Dun C.A., Meessen N.E., Kamps W.A., de Bont E.S., et al. Chemotherapy treatment in pediatric patients with acute myeloid leukemia receiving antimicrobial prophylaxis leads to a relative increase of colonization with potentially pathogenic bacteria in the gut. Clin Infect Dis 2009, 49:262-270.
32. Stringer A.M., Gibson R.J., Logan R.M., Bowen J.M., Yeoh A.S., Keefe D.M. Faecal microflora and beta-glucuronidase expression are altered in an irinotecan-induced diarrhea model in rats. Cancer Biol Ther 2008, 7:1919-1925.
33. Von Bultzingslowen I., Adlerberth I., Wold A.E., Dahlen G., Jontell M. Oral and intestinal microflora in 5-fluorouracil treated rats, translocation to cervical and mesenteric lymph nodes and effects of probiotic bacteria. Oral Microbiol Immunol 2003, 18:278-284.
34. Resta-Lenert S., Barrett K.E. Live probiotics protect intestinal epithelial cells from the effects of infection with enteroinvasive Escherischia coli (EIEC). Gut 2003, 52:988-997.
35. Vandenplas Y. Bacteria and yeast in the treatment of acute and chronic infectious diarrhea. Part I. Bacteria. Clin Microbiol Infect 1999, 5:299-307.
36. Batt R.M., Rutgers H.C., Sancak A.A. Enteric bacteria: friend or foe. J Small Anim Pract 1996, 37:261-267.
37. Vanderhoof J.A., Young R. Probiotics in the United States. Clin Infect Dis 2008, 46:S67-S72.