Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: A double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system

Journal of Clinical Oncology

Volumn 20, Issue 19, 2002, Pages 3956-3963

  El Sayed, S samy ^a   Nabid, A ^a   Shelley, W ^a   Hay, J ^a   Balogh, J ^a   Gelinas, M ^a   MacKenzie, R ^a   Read, N ^a   Berthelet, E ^a   Lau, H ^a   Epstein, J ^a   Delvecchio, P ^a   Ganguly, P K ^a   Wong, F ^a   Burns, P ^a   Tu, D ^a   Pater, J ^a  

^a OTTAWA REGIONAL CANCER CENTRE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; BACITRACIN; CLOTRIMAZOLE; GENTAMICIN; PLACEBO;

ADULT; ARTICLE; CANCER RADIOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERANCE; ECONOMIC ASPECT; FEMALE; HEAD AND NECK CARCINOMA; HUMAN; LOZENGE; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; PAIN ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROPHYLAXIS; QUALITY OF LIFE; RADIATION INJURY; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; STATISTICAL SIGNIFICANCE; TIME; VALIDATION PROCESS;

EID: 0036789706     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2002.05.046     Document Type: Article

References (60)

1. Sonis ST: Oral complications of cancer therapy, in DeVita VT Jr, Hellman A, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology, Vol 2 (ed 4). Philadelphia, JP Lippincott, 1993, p 2385
2. Baker DG: The radiobiological basis for tissue reactions in the oral cavity following therapeutic X-irradiation. Arch Otolaryngol 108:21-24, 1982
3. Sonis ST, Oster G, Fuchs H, et al: Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol 19:2201-2205, 2001
4. Epstein JB, Stewart KH: Radiation therapy and pain in patients with head and neck cancer. Eur J Cancer B Oral Oncol 29B: 191-999, 1993
5. Bennett J: Oral care of cancer patients undergoing head and neck irradiation. Dent Hyg (Chic) 53:209-213, 1979
6. McGuire DB, Yaeger KA, Dudley WN, et al: Acute oral pain and mucositis in bone marrow transplant and leukemia patients: Data from a pilot study. Cancer Nurs 21:85-393, 1998
7. Epstein JB, Schubert MM: Management of orofacial pain in cancer patients. Eur J Cancer B Oral Oncol 29B:243-250, 1993
8. McCarthy GM, Awde JD, Ghandi H, et al: Risk factors associated with mucositis in cancer patients receiving 5-fluorouracil. Oral Oncol 34:484-490, 1998
9. Berger AM, Eilers J: Factors influencing oral cavity status during high-dose antineoplastic therapy: A secondary data analysis. Oncol Nurs Forum 25:1623-1626, 1998
10. Spijkervet FKL, VanSaene HK, Panders AK: Colonization index of the oral cavity: A novel technique for monitoring colonization defense. Microbiol Ecol Health Dis 2:145-151, 1989
11. DeGregorio MW, Lee WM, Ries CA: Candida infections in patients with acute leukemia: Ineffectiveness of nystatin prophylaxis and relationship between oropharyngeal and systemic candidiasis. Cancer 50:2780-2784, 1982
12. Samaranayake LP, Robertson AG, MacFarlane A, et al: The effect of chlorhexidine and benzydamine mouthwashes on mucositis induced by therapeutic irradiation. Clin Radiol 39:291-294, 1988
13. Schiott CR, Loe H, Jensen SB, et al: The effect of chlorhexidine mouth rinses on human oral flora. J Periodontal Res 5:84-89, 1970
14. Ferretti GA, Hansen LA, Whittenburg K, et al: Therapeutic use of chlorhexidine in bone marrow transplant patients: Case studies. Oral Surg Oral Med Oral Pathol 63:683-687, 1987
15. Ferretti GA, Ash RC, Brown AT, et al: Control of oral mucositis and candidiasis in marrow transplantation: A prospective, double-blind trial of chlorhexidine gluconate oral rinse. Bone Marrow Transplant 3:483-493, 1988
16. Ferretti GA: The effects of chlorhexidine on the oral microflora of bone marrow transplant patients. J Dent Res 64:235 1985 (spec issue, abstr)
17. Weisdorf DJ, Bostrom B, Raether D, et al: Oropharyngeal mucositis complicating bone marrow transplantation prognostic factors and the effect of chlorhexidine mouth rinse. Bone Marrow Transplant 4:89-95, 1989
18. Wahlin YB: Effects of chlorhexidine mouth rinse on oral health in patients with acute leukemia. Oral Surg Oral Med Oral Pathol 68:279-287, 1989
19. Spijkervet FKL, VanSaene 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 7:154-161, 1989
20. Holloway PM, Bucknall RA, Denton GW: The effects of sublethal concentrations of chlorhexidine on bacterial pathogenicity. J Hosp Infect 8:39-46, 1986
21. Spijkervet FKL, VanSaene JJ, VanSaene HK, et al: Chlorhexidine inactivation by saliva. Oral Surg Oral Med Oral Pathol 69:444- 449, 1990
22. Epstein JB, Vickers L, Spinelli J, et al: Efficacy of chlorhexidine and nystatin rinses in prevention of oral complications in leukemia and bone marrow transplantation. Oral Surg Oral Med Oral Pathol 73:682-689, 1992
23. Ferretti GA, Raybould TP, Brown AT: Chlorhexidine prophylaxis for chemotherapy and radiotherapy-induced stomatitis: A randomized double-blind trial. Oral Surg Oral Med Oral Pathol 69:331-338, 1990
24. Foote RL, Loprinzi CL, Frank AR: Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis. J Clin Oncol 12:2630-2633, 1994
25. McIlroy P: Radiation mucositis: A new approach to prevention and treatment. Eur J Cancer Care (Engl) 5:153-158, 1996
26. van Saene HKF, Stoutenbeek CP: Selective decontamination. J Antimicrob Chemother 20:462-465, 1987
27. Hartenauer U, Thulig B, Diemer W, et al: Effect of selective flora suppression on colonization, infection and mortality in critically ill patients: A one year, prospective consecutive study. Crit Care Med 19:463-473, 1991
28. Cooperstock MC: Inactivation of endotoxin by polymyxin B. Antimicrob Agents Chemother 6:422-425, 1974
29. van Saene JJM: Significant reduction of faecal endotoxin pool by oral polymyxin E and tobramycin in human volunteers, in van Saene JJM (ed): Update in Intensive Care and Emergency Medicine: Infection Control by Selective Decontamination-The Use of Non-absorbable and Parenteral Agents. Heidelberg, Springer-Verlag, 1989, pp 128-134
30. Bodey GP: Antibiotic prophylaxis in cancer patients: Regimens of oral, non-absorbable antibiotics for prevention of infection during induction of remission. Rev Infect Dis 3:259-268, 1981 (suppl)
31. Wijers O, Levendag P, Harms E, et al: Mucositis reduction by selective elimination of oral flora in irradiated cancers of the head and neck: A placebo-controlled double blind randomized study. Int J Radiat Oncol Biol Phys 50:343-352, 2001
32. Spijkervet FKL: Irradiation Mucositis and Oral Flora: Reduction of Mucositis by Selective Elimination of Oral Flora, Groningen, University of Groningen, 1989 (thesis)
33. Spijkervet F, van Saene HK, van Saene JJ, et al: Effect of selective elimination of the oral flora on mucositis in irradiated head and neck cancer patients. J Surg Oncol 46:167-173, 1991
34. Spijkervet FK, van Saene HK, van Saene J, et al: Mucositis prevention by selective elimination of oral flora in irradiated head and neck cancer patients. J Oral Pathol Med 19:486-489, 1990
35. Foote RL, Loprinzi CL, Gulavita S, et al: Randomized trial of a nonabsorbable antibiotic lozenge for alleviation of radiation-induced mucositis. Proc Am Soc Clin Oncol 15:534, 1996 (abstr 1728)
36. Symonds RP, McIlroy P, Khorrami J, et al: The reduction of radiation oral mucositis by selective decontamination antibiotic pastilles: A placebo-controlled double-blind trial. Br J Cancer 74:312-317, 1996
37. EL-Sayed S, Epstein JB, Minish E, Burns P, Hay J, Laukkanen E: A pilot study evaluating the safety and microbiological efficacy of an economically viable antimicrobial lozenge in patients with head and neck cancer receiving radiation therapy. Head Neck 24:6-15, 2002
38. Sonis ST, Eilers JP, Epstein JB, et al: Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer 85:2103-2113, 1999
39. Epstein JB, Robertson M, Emerton S, et al: Quality of life and oral function in patients treated with radiation therapy for head and neck cancer. Head Neck 23:389-398, 2001
40. Perch SJ, Machtay M, Markiewicz DA, et al: Decreased acute toxicity by using midline mucosa-sparing blocks during radiation therapy for carcinoma of the oral cavity, oropharynx, and nasopharynx. Radiology 197:63-66, 1995
41. Parsons JT: A re-evaluation of split-course technique for squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys 6:1645-1652, 1986
42. Calais G, Alfonsi M: Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst 91:2081-2086, 1999
43. El-Sayed S, Nelson N: Adjuvant and adjunctive chemotherapy in the management of squamous cell carcinoma of the head and neck region: A meta-analysis of prospective and randomized trials. J Clin Oncol 14:838-847, 1996
44. Wang CC, Nakfoor BM, Spiro IJ, et al: Role of accelerated fractionated irradiation for supraglottic carcinoma: Assessment of results. Cancer J Sci Am 3:88-91, 1997
45. Preliminary results of a randomized trial comparing neoadjuvant chemotherapy (cisplatin, epirubicin, bleomycin) plus radiotherapy vs. radiotherapy alone in stage IV (> or = N2, M0) undifferentiated nasopharyngeal carcinoma: A positive effect on progression-free survival-International Nasopharynx Cancer Study Group. VUMCA I trial. Int J Radiat Oncol Biol Phys 35:463-469, 1996
46. Ausili-Cefaro G, Marmiroli L, Nardone L, et al: Prolonged continuous infusion of carboplatin and concomitant radiotherapy in advanced head and neck cancer: A phase I study. Am J Clin Oncol 18:273-276, 1995
47. Tomio L, Zorat PL, Paccagnella A, et al: A pilot study of concomitant radiation and chemotherapy in patients with locally advanced head and neck cancer. Am J Clin Oncol 16:264-267, 1993
48. Chougule PB, Akhtar MS, Akerley W, et al: Chemoradiotherapy for advanced inoperable head and neck cancer: A phase II study. Semin Radiat Oncol 9:58-63, 1999
49. Dobrowsky W, Dobroswky E, Naude J, et al: Conventional vs accelerated fractionation in head and neck cancer. Br J Cancer Suppl 27:S279-S281, 1996
50. Parsons JT, Mendenhal WM, Cassisi NJ, et al: Hyperfractionation for head and neck cancer. Int J Radiat Oncol Biol Phys 14:649-688, 1988
51. Horiot JC, Le-Fur R, N'Guyen T, et al: Hyperfractionation versus conventional fractionation in oropharyngeal carcinoma: Final analysis of a randomized trial of the EORTC cooperative group of radiotherapy. Radiother Oncol 25:231-241, 1992
52. Datta NR: Twice-a-day versus once-a-day radiation therapy in head and neck cancer. Int J Radiat Oncol Biol Phys 17:132-133, 1989
53. Marcial VA, Pajak TF: Concomitant cisplatin chemotherapy and radiotherapy in advanced mucosal squamous cell carcinoma of the head and neck: Long-term results of the Radiation Therapy Oncology Group study 81-17. Cancer 66:1861-1868, 1990
54. Vokes EE, Weichselbaum RR: Favorable long-term survival following induction chemotherapy with cisplatin, fluorouracil and leucovorin and concomitant chemoradiotherapy for locally advanced head and neck cancer. J Natl Cancer Inst 84:877-882, 1992
55. Benchalal M, Bauchaud JM: Hyperfractionation in the reirradiation of head and neck cancers: Result of a pilot study. Radiother Oncol 36:203-210, 1995
56. Merlano M, Benasso M: Five-year update of a randomized trial of alternating radiotherapy and chemotherapy compared with radiotherapy alone in treatment of unresectable squamous cell carcinoma of the head and neck. J Natl Cancer Inst 88:583-589, 1996
57. Jeremic B, Shibamoto Y. Radiation therapy alone or with concurrent low-dose daily either cisplatin or carboplatin in locally advanced unresectable squamous cell carcinoma of the head and neck: A prospective randomized trial. Radiother Oncol 43:29-37, 1997
58. Adelstein DJ, Saxton JP. A phase III randomized trial comparing concurrent chemotherapy and radiotherapy with radiotherapy alone in resectable stage III and IV squamous cell head and neck cancer: Preliminary results. Head Neck 19:567-575, 1997
59. Wendt TG, Grabenbauer GG. Simultaneous radiochemotherapy versus radiotherapy alone in advanced head and neck cancer: A randomized multicenter study. J Clin Oncol 16:1318-1324, 1998
60. Wang CC: Local control of oropharyngeal carcinoma after accelerated hyperfractionated radiotherapy schemes. Int J Radiat Oncol Biol Phys 14:1143-1146, 1988