Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies

Cancer

Volumn 112, Issue 7, 2008, Pages 1600-1606

  Sorensen, Jens Benn ^a   Skovsgaard, Torben ^b   Bork, Ellen ^c   Damstrup, Lars ^a   Ingeberg, Sten ^d  

^a FINSEN LABORATORY   (Denmark)

^b GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^c HILLERØD HOSPITAL   (Denmark)

^d NAESTVED HOSPITAL   (Denmark)

Author keywords

Chlorhexidine; Cryotherapy; Fluorouracil; Oral mucositis

Indexed keywords

CHLORHEXIDINE; FLUOROURACIL; FOLINIC ACID; ICE; PLACEBO; SODIUM CHLORIDE;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CHEMOPROPHYLAXIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRYOTHERAPY; DIGESTIVE SYSTEM CANCER; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG INDUCED HEADACHE; FEMALE; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MOUTHWASH; PATIENT COMPLIANCE; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; STATISTICAL SIGNIFICANCE; STOMATITIS; TASTE DISORDER; TOOTH DISEASE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; CHLORHEXIDINE; CRYOTHERAPY; DOUBLE-BLIND METHOD; FEMALE; FLUOROURACIL; GASTROINTESTINAL NEOPLASMS; HUMANS; ICE; LEUCOVORIN; MALE; MIDDLE AGED; MOUTHWASHES; STOMATITIS; TREATMENT OUTCOME;

EID: 41149105454     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.23328     Document Type: Article

References (34)

1. Popescu RA, Norman A, Ross PH, Parikh B, Cunningham D. Adjuvant of palliative chemotherapy for colorectal cancer in patients 70 years or older. J Clin Oncol. 1999;17:2412-2418.
2. Toxicity of fluorouracil in patients with advanced colorectal cancer: effect of administration schedule and prognostic factors. Meta-Analysis Group in Cancer. J Clin Oncol. 1998;16:3537-3541.
3. Sonis ST, Elting LS, Keefe D, et al. Perspective on cancer therapy-induced mucosal injury. Cancer. 2004;100(9 suppl):1995-2025.
4. Dalberg J, Sorensen JB. Cryotherapy (oral cooling) as prevention of chemotherapy-induced stomatitis. A literature review. J Cancer Care. 1996;5:131-134.
5. Cascinu S, Fedeli A, Fedeli SL, Catalano G. Oral cooling (cryotherapy): an effective treatment for the prevention of 5-fluorouracil-induced stomatitis. Oral Oncol Eur J Cancer. 1994;30:234-236.
6. Mahood DJ, Dose AM, Loprinzi CI, et al. Inhibition of fluorouracil-induced stomatitis by oral cryotherapy. J Clin Oncol. 1991;9:449-452.
7. Rocke LK, Loprinzi CI, Lee JK, et al. A randomized clinical trial of 2 different durations of oral cryotherapy for prevention of 5-fluorouracil-related stomatitis. Cancer. 1993;72:2234-2238.
8. Ferretti GA, Raybould TP, Brown AT, et al. Chlorhexidine prophylaxis for chemotherapy-and radiotherapy-induced stomatitis: a randomized double-blind trial. Oral Surg Oral Med Oral Pathol. 1990;69:331-339.
9. Rubenstein EB, Peterson DE, Schubert M, et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer. 2004;100(9 suppl):2020-2040.
10. Goldberg SL, Chiang L, Selina N, Hamarman S. Patient perceptions about chemotherapy-induced oral mucositis: implications for primary/secondary prophylaxis strategies. Support Care Cancer. 2004;12:526-530.
11. Lilleby K, Garcia P, Gooley T, et al. A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplant. 2006;37:1031-1035.
12. Karagozoglu S, Filiz Ulusoy M. Chemotherapy: the effect of oral cryotherapy on the development of mucositis. J Clin Nurs. 2005;14:754-765.
13. Gori E, Arpinati M, Bonifazi F, et al. Cryotherapy in the prevention of oral mucositis in patients receiving low-dose methotrexate after myeloablative allogeneic stem cell transplantation: a prospective randomized study of the Gruppo Italiano Trapianto di Midollo Osseo nurses group. Bone Marrow Transplant. 2007;39:347-352.
14. Worthington HV, Clarkson JE, Eden OB. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2006;CD000978.
15. Borowski B, Benhamou E, Pico J, Laplanche A, Margainaud J, Hayat M. Prevention of oral mucositis in patients treated with high-dose chemotherapy and bone marrow transplantation: a randomized controlled trial comparing 2 protocols of dental care. Eur J Cancer. B Oral Oncol. 1994;30B:93-97.
16. Dudjak I. Mouth care for mucositis due to radiation therapy. Cancer Nurs. 1987;10:131-140.
17. Kenny S. Effect of 2 oral care protocols on the incidence of stomatitis in hematology patients. Cancer Nurs. 1990;13:345-353.
18. Mcguire D, Owen D, Peterson D. Nursing intervention for acute oral pain and mucositis. Oncol Nurs Forum. 1998;25:341.
19. Andre T, Louvet C, Raymond E, et al. Bimonthly high-dose leucovorin, 5-fluorouracil infusion and oxaliplatin (FOLFOX) for metastatic colorectal cancer resistant to the same leucovorin and 5-fluorouracil regimen. Ann Oncol. 1998;9:1251.
20. Andre T, Colin P, Louvert C, et al. Semimonthly versus monthly regimen of fluorouracil and leucovorin administered foaer 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: results of a randomized trial. J Clin Oncol. 2003;21:2896.
21. Mori T. Yamazaki R, Aisa Y, et al. Brief oral cryotherapy for the prevention of high dose melphalan-induced stomatitis in allogenic hematopoietic stem cell transplant recipients. Support Care Cancer. 1997;14:393-395.
22. Foote RI, Loprinzi CI, Frank AR, et al. Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis. J Clin Oncol. 1994;12:2630-2633.
23. Samaranayake LP, Robertson AG, MacFarlane TW, et al. The effect of chlorhexidine and benzydamine mouthwashes on mucositis induced by therapeutic irradiation. Clin Radiol. 1988;39:291-294.
24. Spijkervet FK, van Saene HK, Panders AK, et al. Effect of chlorhexidine rinsing on the oropharyngeal ecology in patients with head and neck cancer who have irradiation mucositis. Oral Surg Oral Med Oral Pathol. 1988;67:154-161.
25. Dodd MJ, Dibble SL, Miakowski C, et al. Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000;90:39-47.
26. Okuno SH, Foote RI, Loprinzi CI, et al. A randomized trial of a nonabsorbable antibiotic lozenge given to alleviate radiation-induced mucositis. Cancer. 1997;79:2193-2199.
27. Okuno SH, Woodhouse CO, Loprinzi CI, et al. Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy. Am J Clin Oncol. 1999;22:258-261.
28. Barasch A, Elad S, Altman A, Damato K, Epstein J. Antimicrobials, mucosal coating agents, anesthetics, analgesics, and nutritional supplements for alimentary tract mucositis. Support Care Cancer. 2006;14:528-532.
29. Dodd MJ, Larson PH, Dibble SL, et al. Randomized clinical trial of chlorhexidine versus placebo for prevention of oral mucositis in patients receiving chemotherapy. Oncol Nurs Forum. 1996;23:921-927.
30. Luglie PF, Mura G, Mura A, Angius A, Soru G, Farris A. Prevention of periodontopathy and oral mucositis during anti-neoplastic chemotherapy. Clinical study. Minerva Stomatol. 2002;51:231-239.
31. Cheng KK, Chang AM, Yuen MP. Prevention of oral mucositis in paediatric patients treated with chemotherapy: a randomised crossover trial comparing 2 protocols of oral care. Eur J Cancer. 2004;40:1208-1216.
32. Spielberger R, Stiff P, Bensinger W, et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med. 2004;351:2590-2598.
33. Stiff PJ, Emmanouilides C, Bensinger WI, et al. Palifermin reduces patient-reported mouth and throat soreness and impoves patient functioning in the hematopoietic stem-cell transplantation setting. J Clin Oncol. 2006;24:5186-5193.
34. Rosen LS, Abdi E, Davis ID, et al. Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. J Clin Oncol. 2006;24:5194-5200.