Table 3.
Summary table of results of clinical studies.
| Author, Year | Population | Intervention | Outcome/Effect Observed |
|---|---|---|---|
| Osaki et al., 1994 [6] | CT pts. | Azelastine + Vitamin C + Vitamin E + Glutathione | Delayed and less severe inflammation in Azelastine intervention. |
| Cirillo et al., 2015 [19] | Pts. receiving radio- and/or CT | Mucosamine | Prevention or reduced grade of OM |
| Rupel et al., 2018 [20] | Pts. affected by grade 2 or 3 OM aged 40–95 years, diagnosed with solid or hematologic malignancy undergoing CT and/or RT, and available to undergo PBM for 4 consecutive days | Photobiomodulation | 660 nm laser light increases ROS, whereas the 970 nm light exerted a moderate antioxidant activity. The 800 nm light or the combination of the 3 wavelengths resulted in the largest ROS reduction. |
| Sung et al., 2007 [65] | Children aged 6–17 years old undergoing CT | Vitamin E | No significant difference in objective mucositis scores |
| Ferreira et al., 2004 [66] | Pts. with oral cavity and oropharynx cancer | Vitamin E | Vitamin E reduced pain grades. |
| El- Housseiny et al., 2007 [67] | Cancer pts. receiving CT | Vitamin E | Vitamin E resulted in complete resolution of OM in 80% of pts. |
| Wadleigh et al., 1992 [68] | Pts. receiving CT for malignancy | Vitamin E | Vitamin E resulted in relatively more instances of complete resolution of OM. |
| Sayed et al., 2019 [69] | HNC pts. receiving 30–35 RT fractions with or without CT | Pentoxifylline and vitamin E | Pentoxifylline and vitamin E did not affect the incidence of OM, however, after adjusting for age, it decreased the incidence of severe OM and decreased the duration of OM |
| Agha- Hosseini et al., 2021 [70] | Pts. with H&N cancer undergoing RT | Vitamin E + triamcinolone + HA | Reduction in OM grade and pain intensity |
| Khurana et al., 2013 [71] | Children with CT-induced OM | Vitamin E or Pycnogenol | Both interventions equally effective at reducing OM severity and pain. |
| Venkatesh et al., 2014 [72] | HNC pts. undergoing CRT or RT | None- observational study of association of genetic polymorphism with OM | NBN variants are of predictive significance in analysing oral mucositis prior to radiotherapy. |
| Pratesi et al., 2011 [73] | SCCHN pts. following RT | None—observational study of genetic polymorphisms | XRCC1-399Gln allele significantly associated with higher risk of OM, with increased incidence of higher grades. |
| Urbain et al., 2012 [74] | Adults treated with alloHCT with CT | None—prospective study of AOX concentrations relative to OM severity | No single AOX had predictive value for severity or incidence of OM. |
| Wardman et al., 2013 [75] | HNC treated with CHART | None—observational study of correlation of plasma AOX and OM severity | No correlation between mucositis severity and measures of plasma AOX. |
| Bachmeier et al., 2014 [76] | BMT pts. | None- observational study measuring changes in AOX activity | Post BMT, 85% developed OM, increase in SOD and decrease in UA during M-stage |
| Severin et al., 2005 [77] | Leukemia pts. receiving BMT and healthy blood donors | None- observational study of AOX capacity before and after radiation | Severe OM associated with specific depletion in leukocyte, lymphocyte and plasma antioxidant concentration |
| Chaitanya et al., 2017 [78] | CRT pts. | Rebamipide | Decreased OM severity and pain intensity, delayed onset |
| Ishii et al., 2017 [79] | Stomatitis pts. with CT | Rebamipide | Rebamipide pts experienced improvements or eliminations of SES score. |
| Gholizadeh et al., 2017 [80] | Pts. with AML undergoing CT | Zinc sulfate | Frequency of severe OM reduced |
| Doi et al., 2015 [81] | Newly diagnosed pts. with HNC and undergoing RT | Polaprezinc | Decreased incidence of grade 3 OM, promoted recovery |
| Büntzel et al., 2010 [82] | RT pts. | Selenium | No significant difference was observed. |
| Jahangard-Rafsanjani et al., 2013 [83] | Leukaemia pts. undergoing HSCT with HDC | Selenium | Selenium had an effect on incidence of severe OM (reduced), and its duration (reduced). Glu.Px increased in intervention arm. |
| Bardellini et al., 2016 [84] | Paediatric pts. receiving CT for ALL | Mucosyte | Intervention demonstrated declines in OM and pain. |
| Tacyildiz et al., 2010 [85] | Children undergoing CT + RT | Genistein | Less OM occurred with genistein treatment. |
| Wu et al., 2010 [86] | Nasopharyngeal cancer pts. receiving CRT + induction CT | Actovegin | Actovegin group had fewer incidences of grade 2, 3 OM, and reduced patient pain grading in preventive arm. |
| Anderson et al., 2019 [87] | Pts. with locally advanced oral or oropharyngeal cancer | GC4419 | Dose of 30 mg produced intermediate improvements, and at a dose of 90 mg produced reduced duration, incidence and severity of severe OM. |
| Yokomizo et al., 2004 [88] | Pts. with advanced or recurrent colon cancer | Allopurinol ice | Decreased incidence and severity |
| Hosseinjani et al., 2017 [89] | Adults with non-Hodgkin’s lymphoma, Hodgkin disease or multiple myeloma undergoing autologous HSCT | Erythropoietin | Significant reduction in the incidence and duration of OM |
| Vidal-Casariego et al., 2013 [90] | Pts. treated with RT for H&N or cancer in chest area | Glutamine | Decreased risk of developing OM and ARIE |
| Moslehi et al., 2014 [91] | Pts. with AML, ALL or MDS undergoing HSCT with HDC | NAC | Duration and frequency (severe only) of OM reduced in NAC group. Glu.Px increased in intervention arm. |
| Salehi et al., 2018 [92] | Colon cancer pts. | Propolis | Propolis group had significantly reduced severity of OM relative to placebo. |
| Naidu et al., 2005 [93] | CRT induced OM pts | MF5232 | OM grade improves with intervention. |
| Elsabagh et al., 2019 [94] | HNC pts. receiving RT | Melatonin | Discomfort/pain lower in intervention arm. TAC reduced in control group. |
| Elkerm et al., 2014 [95] | Pts. with H&N cancer prior to exposure to first-line treatment | Date palm pollen | Significantly reduced OMAS score and pain severity of OM |
| Mills, 1998 [96] | Pts. with SCC undergoing CT | Beta-carotene supplementation | Intervention arm developed severe disease later and to a lesser extent. |
| Babaee et al., 2013 [97] | H&N cancer pts. | Calendula officinalis flower | Lower OMAS |
ALL = acute lymphoblastic leukemia; alloHCT = allogenic hematopoietic cell transfer; AML = acute myeloblastic leukemia; AOX = antioxidant; ARIE = Acute radiation-induced esophagitis; BMT = Bone marrow transplant; CHART = Continuous Hyperfractionated Accelerated RadioTherapy; CRT = chemoradiation; CT = chemotherapy; HA = hyaluronic acid; H&N = Head and Neck; HDC = high-dose chemotherapy; HNC = head and neck cancer; HSCT = hematopoietic stem cell transfer; MDS= myelodysplastic syndrome; NAC = N-acetyl cysteine; OMAS = Oral mucositis assessment scale; OM = oral mucositis; PBM = photobiomodulation; Pts. = patients; RT= radiotherapy; SCC = squamous cell carcinoma; SCCHN = squamous cell carcinoma of the head and neck; SES = stomatitis evaluation score; SOD = superoxide dismutase; TAC = total antioxidant capacity; UA = uric acid.