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TABLE 3 Clinical trials on prevention and treatment of oral mucositis

RT, CT, BMT Author Randomized/Controlled/Double-blind P/T Application/Doses Results 1. Locally applied nonpharmacological methods a) Oral hygiene RT Shieh et al.55 yes/yes/no P instructions on oral care significant reduction Rugg et al.32 no/no/no P smoking during RT higher mucositis incidence in smokers CT Greenberg et al.44 no/yes/no P dental treatment prior to CT significant reduction of septicemia CT+RT Sonis et al.36 Sonis et al.36 P early and aggressive dental intervention reduced frequency of oral complications BMT Peters et al.52 no/no/no P treatment of asymptomatic periapical radiolucencies no difference in infectious complications BMT Borowski et al.35 yes/yes/no P intensive vs. regular oral care significant reduction of mucositis but not septicemia b) Radiation shields RT Perch et al.106 no/no/no P midline mucosa sparing blocks decreased mucositis without affecting tumor control Keus et al.104 no/yes/no P customized beam shaping lower incidence of mucositis c) Soft lasers BMT Barasch et al.109 yes/yes/no P laser on one buccal side, placebo light to the other significant reduction Cowen et al.110 yes/yes/no P laser vs. no treatment significant reduction of incidence CT Ciais et al.107 no/yes/no P+T soft laser treatment soft laser treatment of mucositis d) Cryotherapy CT Mahood et al.67 yes/yes/no P oral cryotherapy vs. no prophylaxis significant lower incidence Rocke et al.65 yes/yes/no P 30 vs. 60 minutes of cryotherapy during equivalent Cascinu et al.66 yes/yes/no P oral cryotherapy vs. no prophylaxis significant lower incidence Edelman et al.68 no/yes/no P ice chips during dose escalation of edatrexate lower incidence of mucositis Gandara et al.69 no/yes/no P ice chips during edatrexate-based CT lower incidence of severe mucositis 2. Locally applied pharmacotherapeutics e) Mouth-coating agents Sucralfate CT Loprinzi et al.130 yes/yes/yes T sucralfate vs. placebo after cryoprophylaxis no difference RT Scherlacher et al.120 yes/yes/no P sucralfate vs. standard oral hygiene significant reduction of incidence and severity of mucositis Allison et al.121 yes/yes/no P+T sucralfate+fluconazole vs. standard oral care significant reduced severity and symptomatic relief Franzen et al.122 yes/yes/yes P sucralfate vs. placebo sig. lower incidence of severe mucositis Makkonen et al.123 yes/yes/yes P sucralfate vs. placebo only slight protective effect of sucralfate Epstein et al.125 yes/yes/yes P+T sucralfate vs. placebo nonsignificant reduction of oral discomfort Meredith et al.124 yes/yes/yes T antacid,diphenhydramine, lidocaine ± sucralfate nonsignificant reduction of severity Cengiz et al.229 yes/yes/yes P+T sucralfate vs. placebo decreased severity Carter et al.126 yes/yes/yes P sucralfate vs. placebo no difference Kaolin-pectin RT Barker et al.101 yes/yes/yes P+T oral hygiene+sucralfate vs. diphenhydramine+kaolin-pectin no difference f) Antiseptic and antibiotic agents Hydrogen peroxide RT Feber et al.211 yes/yes/no P hydrogen peroxide vs. saline significantly more oral discomfort Chlorhexidine RT Spijkervet et al.207 yes/yes/yes P+T chlorhexidine vs. placebo no difference Foote et al.208 yes/yes/yes P chlorhexidine vs. placebo slight aggravation BMT Ferretti et al.78 yes/yes/yes P chlorhexidine vs. placebo significant reduction of incidence and duration, less candidemia Weisdorf et al.205 yes/yes/yes P chlorhexidine vs. placebo no difference Rutkauskas et al.204 yes/yes/yes P chlorhexidine vs. placebo significant reduction HD-CT+RT Feretti et al.12 Feretti et al.12 P+T chlorhexidine vs. placebo significant reduction of incidence and severity in the CT group only CT McGaw et al.203 yes/yes/yes P chlorhexidine vs. placebo significant reduction Wahlin et al.206 yes/yes/yes P chlorhexidine vs. standard oral care slight aggravation CT+BMT Epstein et al.81 yes/yes/no P nystatin, saline ± chlorhexidine no difference PVP-iodine CT+RT Rahn et al.161 yes/yes/no P nystatin, rutosides, immuno-globuines, panthenol±PVP-iodine significant reduction Adamiez et al.165 yes/yes/no P nystatin, rutosides, immuno-globuines, panthenol±PVP-iodine significant reduction Hasenau et al.162 no/yes/no P hydrogen peroxide, PVP iodine, dexpanthenol, nystatin lower incidence and severity of oral mucositis Selective decontamination Spijkervet et al.71 no/yes/no P lozenges of polymyxin, tobramycin,amphotericin vs. historical controls lower incidence of mucositis Mattews et al.98 yes/yes/no P sucralfate+(ciprofloxacin or ampicillin)+ clotrimazole vs. sucralfate sig. reduction of incidence and severity Symonds et al.90 yes/yes/yes P pastilles containing polymyxin, tobramycin, amphothericin vs. placebo significant reduction of severe mucositis Okuno et al.89 yes/yes/yes P+T lozenges of polymyxin, tobramycin, amphotericin vs. placebo significant reduction of oral discomfort, no objective difference BMT Bondi et al.88 yes/yes/no T polymyxin, tobramycin, amphothericin, chlorhexidine vs. diphenhydramine, magnesium- and aluminium-hydroxide, lidocaine antibiotic regimen more effective g) Antifungal agents Nystatin BMT+CT Barrett et al.82 no/yes/no P topical nystatin during granulocytopenia no impact upon candida infections Epstein et al.81 no/yes/no P chlorhexidine+nystatin+saline vs. historical controls no reduction in mucositis incidence CT Carpentieri et al.80 no/yes/no P nystatin prophylaxis lower incidence of mucositis Williams et al.83 yes/yes/no P nystatin vs. natamycin vs. no prophylaxis no difference Clotrimazole CT Aviles et al.86 no/yes/no P topical clotrimazole lower incidence of oral candidiasis Yeo et al.84 yes/yes/no P topical clotrimazole vs. no prophylaxis lower incidence of orophayngeal candidiasis Yap et al.85 yes/yes/yes T 50 mg vs. 10 mg clotrimazole troches 50 mg troches more effective in manifest oropharyngeal candidiasis Fluconazole CT Samonis et al.87 yes/yes/yes P fluconazole p.o. vs. placebo lower incidence of oropharyngeal candidiasis Amphotericin B CT Bondi et al.88 no/yes/yes T amphotericin+tobramycin+ polymyxin vs. diphenhydramine, aluminium- and magnesiumhydroxide+local anesthetic superior activity RT Okuno et al.89 yes/yes/no T amphotericin+colistin+tobramycin+chlorhexidine vs. placebo decreased oral discomfort Symonds et al.90 yes/yes/yes P amphotericin+tobramycin+polymyxin vs. placebo significant reduction of the incidence of severe mucositis Spijkervet et al.71 no/yes/no P amphotericin+tobramycin+polymyxin vs. historical chlorhexidine or placebo group significant reduction of severity of mucositis h) Anti-inflammatory agents Chamomile RT Carl et al.113 no/yes/no P+T chamomile vs. historical group low incidence of mucositis Fidler et al.114 yes/yes/yes P chamomile vs. placebo, cryoprophylaxis in all patients no difference Betamethasone RT Abdelaal et al.163 no/no/no P high-dose betamethasone impressive prevention of mucositis incidence Benzydamine RT Kim et al.117 yes/yes/yes P+T benzydamine vs. placebo significant reduction (less pain) Epstein et al.115 yes/yes/yes P+T benzydamine vs. placebo significant reduction of incidence and severity Samaranayake et al.118 yes/no/no P benzydamine vs. chlorhexidine no difference (more discomfort) CT+RT Prada et al.116 yes/yes/yes P+T benzydamine vs. placebo significant reduction i) Cytoprotectants Allopurinol CT Tsavaris et al.197 no/yes/no P allopurinol mouthwashes in pats. with mucositis history lower incidence of mucositis Clark et al.198 no/yes/no P allopurinol mouthwashes in pats. with mucositis history lower incidence of mucositis Loprinzi et al.200 yes/yes/yes P allopurinol mouthwashes vs. placebo no difference Glutamine RT Huang et al.140 yes/yes/yes P glutamine suspension vs. placebo sig. reduction of severity and duration CT Van Zaanen et al.143 yes/yes/yes P parenteral glutamine vs. placebo no difference CT Anderson et al.139 yes/yes/yes P glutamine suspension vs. placebo reduces severity and incidence of mucositis CT Jebb et al.141 yes/yes/yes P oral glutamine vs. placebo no difference BMT Anderson et al.142 yes/yes/yes P oral glutamine vs. placebo significant reduction of mucositis Prostaglandin E2 CT+RT Porteder et al.131 no/yes/no P PGE2 or nothing significant reduction (less pain) RT Matejka et al.133 no/yes/no T PGE2 tablets four times a day reduction of mucositis severity BMT Labar et al.134 yes/yes/yes P PGE2 vs. placebo no difference Vitamin E CT Wadleigh et al.137 yes/yes/yes T topical vitamin E vs. placebo accelerated healing in vitamin E group j) Multiagent mouthrinses CT+RT Hasenau et al.162 no/no/no P+T hydrogen peroxide, nystatin, PVP-iodine, dexpanthenol lower incidence of mucositis RT Rothwell et al.164 yes/yes/yes P hydrocortisone, nystatin, tetracyclines, diphenhydramine vs. placebo significant reduction of incidence k) Agents influencing mucosal proliferation Silver nitrate RT Maciejewski et al.144 no/yes/no P applied to one side of buccal mucosa significant reduction compared with contralateral side Dorr et al.145 no/yes/no P applied to one side of buccal mucosa no difference compared with contralateral side Tretinoin BMT Cohen et al.136 yes/yes/no P 0.1% topical tretinoin cream vs. controls significant reduction of mucositis incidence Transforming growth factor β3 CT Wymenga et al.147 no/yes/no P TGFβ3 mouthwashes deserve further studies l) Hematopoetic growth factors GM-CSF BMT Bez et al.151 no/yes/no T GM-CSF mouthrinses accelerated healing as compared with historical control Ovilla-Martinez et al.152 no/yes/no T GM-CSF mouthwashes accelerated healing as compared with historical control CT Haus et al.153 no/yes/no T topical GM-CSF reduction of duration and severity of mucositis Ibrahim et al.17 no/yes/no T GM-CSF mouthwashes accelerated healing and reduction of severity of oral mucositis Cinat et al.154 no/yes/no T GM-CSF mouthwashes accelerated healing of oral mucositis Lira-Puerto et al.155 no/yes/no T GM-CSF mouthwashes accelerated healing of oral mucositis Hejna et al.158 yes/yes/no T GM-CSF mouthwashes vs. PVP-iodine, amphotericin and lidocaine significant reduction of severity and duration Berberoglu et al.156 no/yes/no T GM-CSF mouthwashes accelerated healing of mucositis Cartee et al.159 yes/yes/yes P GM-CSF mouthwashes vs. placebo higher incidence of mucositis in the GM-CSF group G-CSF BMT Karthaus et al.160 yes/yes/no P G-CSF mouthwashes vs. placebo lower incidence of severe mucositis m) Local anesthetics CT Le Veque et al.100 no/yes/no T benozcaine+mouth coating agent significant reduction of oral discomfort RT Barker et al.101 yes/yes/yes P+T oral hygiene+sucralfate vs. diphenhydramine+kaolin-pectin no difference CT+RT Berger et al.167 no/yes/no T capsaicin in a candy vehicle significant temporary pain relief Carnel et al.99 yes/yes/yes T viscous lidocaine +cocaine vs. dyclonine vs. kaolin-pectin+ diphenhydramine+ saline vs. placebo favored dyclonine 3) Systemically applied pharmacotherapeutics n) Agents influencing mucosal proliferation Beta carotene CT+RT Mills et al.190 yes/yes/no P betacarotene or nothing decreased severity in the treatment group o) Cytoprotectants Amifostine RT Bourhis et al.181 yes/yes/no P amifostine or nothing marked reduction of mucositis (tolerance was poor) Koukourakis et al.180 yes/yes/yes P amifostine vs. saline significant reduction of mucositis Schonekas et al.182 no/yes/no P amifostine vs. controls significant reduction of mucositis Wagner et al.186 yes/yes/no P amifostine or nothing significant reduction of mucositis CT+RT Buntzel et al.183 yes/yes/no P amifostine or nothing sig. reduction of mucositis and xerostomia Peters et al.184 yes/yes/no P amifostine or nothing no significant difference Vacha et al.185 yes/yes/no P amifostine or nothing trend towards reduction of mucositis trend towards reduction of mucositis De Souza et al.187 no/yes/no P amifostine or nothing significant reduction of mucositis compared with historical control TBI Gabriel et al.188 no/yes/no P amifostine or nothing significant reduction of mucositis compared with historical control CT Fahlke et al.189 no/yes/no P amifostine or nothing significant reduction of mucositis compared with historical control Glutamine Glutamine CT Jebb et al.141 yes/yes/no P glutamine or placebo no difference Azelastine CT+RT Osaki et al.191 yes/yes/no P Vitamins C+E, glutathione ± azelastine significant reduction Allopurinol CT Ahmann et al.199 no/yes/no P HD-5-FU + IV allopurinol vs. historical control no difference Weiss et al.201 yes/yes/no P allopurinol or nothing no difference Uridine CT Seiter et al.202 no/yes/no P uridine rescue after HD-5-FU no sig. reduction of mucositis incidence Propantheline Ahmed et al.192 yes/yes/no P propantheline vs. placebo significant lower incidence and severity of mucositis p) Immunmodulatory drugs Pentoxifylline BMT Bianco et al.213 no/no/no P IV pentoxifylline (PTX) prophylaxis less mucositis compared with control group Clift et al.214 yes/yes/no P oral PTX vs. placebo no difference Stockschlader et al.215 no/yes/no P IV PTX vs. historical controls significant aggravation significant aggravation Attal et al.216 yes/yes/yes P oral PTX vs. placebo no difference van der Jagt et al.217 no/yes/no P oral PTX vs. historical controls no difference CT Verdi et al.219 yes/yes/yes P oral PTX vs. placebo no difference Indomethacin RT Pillsbury et al.135 yes/yes/yes P indomethacin vs. placebo significant delay of mucositis onset Immunoglobulines CT+RT Mose et al.166 no/yes/no p i.m. immunoglobulins significant reduction in CT+RT patients, no difference in RT q) Hematopoetic growth factors GM-CSF CT Ho et al.168 no/yes/no P CT+GM-CSF lower incidence of mucositis Archimbaud et al.171 no/yes/no P CT+GM-CSF vs. historical controls no difference in mucositis incidence Chi et al.16 yes/yes/no P CT+GM-CSF significant reduction of incidence and severity and duration of mucositis BMT Atkinson et al.172 no/yes/no P BMT+GM-CSF vs. historical controls no sig. difference in mucositis incidence Nemunaitis et al.170 yes/yes/yes P myeloablative CT ± GM-CSF sig. lower incidence of severe mucositis Gordon et al.169 no/yes/no P HD-CT±TBI±GM-CSF shorter duration of mucositis in TBI+GMCSF vs. TBI alone RT Wagner et al.176 no/yes/no P RT + GM-CSF vs. historical control significant lower severity of mucositis Makkonen et al.177 yes/yes/no P sucralfate ± GM-CSF no difference Kannan et al.230 no/yes/no P RT+GM-CSF lower incidence of severe mucositis lower incidence of severe mucositis CT+RT Rosso et al.231 no/yes/no P GM-CSF vs. historical control sig. lower incidence of severe mucositis G-CSF CT Gabrilove et al.173 no/yes/no P CT+G-CSF vs. historical controls significant lower incidence and severity of mucositis Crawford et al.175 yes/yes/yes P G-CSF vs. placebo significant reduced incidence of mucositis Pettengell et al.4 yes/yes/no P CT±G-CSF no difference in severe mucositis Welte et al.232 yes/yes/no P CT±G-CSF lower incidence of mucositis RT Mascarin et al.179 yes/yes/no P RT±G-CSF less treatment interruptions only Schneider et al.178 yes/yes/yes P RT±G-CSF sig. reduced incidence of severe mucositis BMT Locatelli et al.233 no/yes/no P BMT±G-CSF no difference r) Antiviral agents Acyclovir CT+RT Bubley et al.95 yes/yes/yes P acyclovir vs. placebo no impact upon incidence and severity of mucositis BMT Woo et al.94 no/yes/no P acyclovir prophylaxis no impact upon incidence and severity of mucositis Epstein et al.93 no/yes/no P acyclovir prophylaxis no impact upon incidence and severity of mucositis RT = Radiotherapy P/T = Prevention or Treatment CT = Chemotherapy HD-CT = High-dose Chemotherapy BMT = Bone Marrow Transplantation TBI = Total Body Irradiation

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