Table 3.
Clinical trials of various preventions in RIOM.
| No. | References | Sample size | Prevention | Evaluation criteria | Design | Result |
|---|---|---|---|---|---|---|
| 1 | Chaitanya et al. (103) | 60 | Rebamipide gargle vs. placevo | RIOM severity | Double blind, randomized | Onset of RIOM: 14.63 d vs. 11.17 d |
| 2 | Mantovani et al. (104) | 68 | GM-CSF | ≥Grade III RIOM incidence and duration | Phase II, non-randomized | 50% of patients developed RIOM |
| 3 | Diaz-Sanchez et al. (105) | 7 | Bioadhesive chlorhexidine gel 0.2% | Gradation and pain of RIOM | Double-blind, randomized | No clinical improvement |
| 4 | Demir Doǧan et al. (106) | 80 | Black mulberry molasses | Incidence and severity of RIOM | Randomized Controlled | An independent and significant factor. [HR 0.63] |
| 5 | Genot-Klastersky et al. (107) | 62 | LEL | The therapeutic success rate | Prospective | The success rate:81% (95% CI = 61–93%) |
| 6 | Elyasi et al. (108) | 27 | Silymarin (420 mg/d) | Severity of RIOM | Randomized, double-blinded, placebo-controlled | Delayed serious RIOM occurrence. |
| 7 | Zanin et al. (109) | 72 | LLLT (λ = 660 nm) | Grade I-III RIOM incidence and pain | Observational, placebo-controlled | Patients treated with LLLT usually did not present with RIOM or pain. |
| 8 | Etiz et al. (110) | 44 | Oral suspensions of sucralfate | Oral mucosal pain and dysphagia | Prospective, randomized, double-blind, placebo-controlled | Reduced oral pain scores. |
| 9 | Gouvêa de Lima et al. (111) | 75 | LLLT vs. placebo | RIOM severity and the number of RT interruptions | Phase III; randomized; double-blind | Grade 3 or 4 RIOM patients: 4 vs. 5 (Week 2, p = 1.0), 4 vs. 12 (Week 4, p = 0.08), and 8 vs. 9 (Week 6, p = 1.0), respectively. |
| 10 | Hamstra et al. (112) | 60 | Placebo vs. D-met | ≥Grade II RIOM incidence | Double-blind placebo-controlled multicenter phase II | Grades 3 to 4 mucositis: 48 vs. 24% (P = 0.058) |
| 11 | Elkerm and Tawashi (113) | 20 | DPP | OMAS | Placebo-controlled; observational | Mean oral pain level: 0.7(Day1); 0.07 (Day15); 0 (Day 29) |
| 12 | Cheng et al. (114) | 42 | Oral care | RIOM incidence and pain | Prospective; observational | A 38% reduction in the incidence of ulcerative mucositis. |
| 13 | Watanabe et al. (115) | 31 | Polaprezinc | ≤Grade III RIOM incidence and pain | Randomized; observational | Complete plus partial response rate: 88% |
| 14 | Giacomelli et al. (116) | 40 | Orasol Plus (Lapacho-based medication) | ≤Grade III RIOM incidence | Phase II | Grade 3: 4 (10%) patients; Grade 4:0 |
| 15 | Trotti et al. (117) | 545 | Iseganan HCl (a synthetic peptide) | ≥Grade II RIOM incidence | Phase III; multinational, randomized, double-blind, controlled | 9% of the patients did not develop ulcerative OM (Grades 2, 3, 4) (p = 0.998) |
| 16 | Zhu et al. (118) | 20 | Epigallocatechin-3-gallate (EGCG) | Safety of EGCG | Phase I; prospective, non-randomized, | No patients experienced ≥Grade III RIOM; the recommended dose of EGCG is 1,760 μmol/L. |
RIOM, radiation-induced oral mucositis; GM-CSF, granulocyte-macrophage colony stimulating factor; HR, hazard ratio; CI, confidence interval; CCRT, concurrent chemoradiation therapy; LLLT, low-level laser therapy; Low-energy laser, LEL; D-met; D-methionine; DPP, date palm pollen; OMAS, Oral Mucositis Assessment Scale.