Oral Mucositis Grade Research Articles

ANTI-INFLAMMATORY POTENTIAL OF ALOE VERA IN ORAL MUCOSITIS THERAPY: SYSTEMATIC REVIEW

This review aims to analyse the potency of Aloe vera for Oral Mucositis (OM) therapy. Articles searched using the keywords “Oral Mucositis” AND “Aloe vera”, conducted through PubMed, ScienceDirect, and Cochrane Library databases, and adapted to the PICO (Population, Intervention, Comparison, Outcome) framework. The inclusion criteria for articles were: Randomized Controlled Trial (RCT) study design; in English; full paper available; published in the range between 2011-2021 and with low risk of bias. RoB-tools JADAD Oxford Quality Scoring System was used. This paper writing refers to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. A total of 5 (five) articles met the criteria for a qualitative review and all showed a high range of quality articles. It was found that both Aloe vera solution 70% and Aloe vera gel 10% showed a reduction of radiotherapy or chemotherapy-induced oral mucositis grade. Aloe vera mouthwash has an equal anti-inflammation effect compare to benzydamine on the patient with radiotherapy-induced oral mucositis, whereas the use of other formula containing Aloe vera with other herbal materials did not show an anti-inflammatory effect. Drug formulation containing Aloe vera can be used as an alternative therapy in the management of Oral Mucositis (OM) with anti-inflammatory potency that can reduce pain and the severity of oral mucositis.

A phase Ⅱ prospective trial of photobiomodulation therapy in limiting oral mucositis in the treatment of locally advanced head and neck cancer patients.

This study aimed to compare the historical incidence rate of severe oral mucositis (OM) in head and neck cancer patients undergoing definitive concurrent chemoradiation therapy (CRT) versus a prospective cohort of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) treated with prophylactic photobiomodulation therapy (PBMT). This US-based, institutional, single-arm, phase Ⅱ prospective clinical trial was initiated in 50 patients (age ≥ 18 years, Karnofsky Performance Scale Index > 60, with locally advanced HNSCC (excluding oral cavity) receiving definitive or adjuvant radiation therapy (RT) with concurrent platinum-based chemotherapy (CT). PBMT was delivered three times per week throughout RT utilizing both an intraoral as well extraoral delivery system. Primary outcome measure was incidence of severe OM utilizing both the National Cancer Institute Common Toxicity Criteria, version 4.0 (NCI-CTCAE) Grade ≥3 and the World Health Organization Mucositis Grading Scale (WHO) Grade ≥3 versus historical controls; secondary outcome measures included time to onset of severe OM following therapy initiation. At baseline, all patients included in final analysis (N = 47) had OM Grade 0. Average RT and CT dose was (66.3 ± 5.1) Gy and (486.1 ± 106.8) mg/m2, respectively. Severe OM was observed in 11 of 47 patients (23%, confidence interval: 12, 38). OM toxicity grade trended upward during treatment, reaching a maximum at 7 weeks (WHO: 1.8 vs. NCI-CTCAE: 1.7). Subsequently, OM grade returned to baseline 3 months following completion of RT.The mean time toonset of severe OM was (35 ± 12) days. The mean time to resolution of severe OM was (37 ± 37) days. Compared to historical outcomes, PBMT aides in decreasing severe OM in patients with locally advanced HNSCC. PBMT represents a minimally invasive, prophylactic intervention to decrease OM as a major treatment-related side effect.

Phase 2, randomized, double-blind trial of EC-18 versus placebo to mitigate the development and time course of oral mucositis from concomitant chemoradiation for head and neck cancer.

12106 Background: Oral mucositis (OM) is a debilitating side effect of concomitant chemoradiotherapy (CRT) for head and neck cancer (HNC). EC-18 may effectively mitigate OM by minimizing the CRT-induced innate immune response. This Phase II, 2-stage trial evaluated safety, tolerability, and efficacy of EC-18 in reducing the duration, incidence, and trajectory of severe OM (SOM) in HNC patients. Methods: Patients (n = 105) with pathologically confirmed oral cavity, oropharynx, hypopharynx, or nasopharynx squamous cell cancers who received intensity-modulated radiation therapy (IMRT; with ≥ 55 Gy on ≥ 2 oral sites) and weekly or tri-weekly cisplatin were studied. In Stage 1, 24 patients were randomized (n = 6 per arm) to receive 500, 1000, or 2000 mg of EC-18, or placebo. Following independent Data Safety Monitoring Board review, 81 patients in Stage 2 received EC-18 2000 mg (n = 41) or placebo (n = 40) throughout CRT. WHO OM grade was assessed twice weekly during IMRT and then once weekly for up to 6 weeks post-IMRT. The primary efficacy endpoint was duration of SOM during the active and short-term follow-up (STFU) periods in the compliant per-protocol population (PP). Much of Stage 2 was conducted during peak periods of the COVID-19 pandemic which measurably impacted patient compliance relative to test medication dosing and planned radiation. Consequently, to assess efficacy most accurately, the PP population was analyzed (with at least 4 weeks of study drug dosing, minimum cumulative radiation of 55 Gy, 80% study drug compliance in the first 28 days of dosing, and without using not-allowed-therapy). Results: Patient demographics and baseline characteristics were balanced between groups. Adverse events (AEs) were comparable amongst cohorts without drug-related severe AEs. In the PP, the median duration of SOM from baseline through STFU was 0 day in the EC-18 group (n = 22) v 13.5 days in the placebo group (n = 20). SOM incidence through STFU (45.5% v 70%) and opioid use (time to onset: 32.3 v 26.0 days; and duration: 32.8 v 37.5 days) favored EC-18 v placebo. Results of the covariates analyses suggested that EC-18 favorably impacted SOM incidence in patients who experienced SOM treated with weekly low-dose cisplatin (n = 26; 37.5% v placebo 70.0%) and HPV+ tumors (n = 29; 35.3% v placebo 66.7%; Table). One-year long-term follow-up for tumor outcomes is ongoing. Conclusions: EC-18 safely mitigated the development and the time course of SOM in CRT-treated HNC patients. In addition, EC-18 may provide substantial benefits to subpopulations of HPV+ HNC patients treated with low dose cisplatin. Clinical trial information: NCT03200340. [Table: see text]

Effectiveness of Cryotherapy on Radiation Induced Oral Mucositis among patients who receive Radiation Therapy at KMCH, Coimbatore

The aim of the present study was to evaluate the Effectiveness of Cryotherapy on Radiation Induced Oral Mucositis among patients who receive Radiation Therapy. The Methodology: Research design adopted for this study was quasi-experimental pre-test and post-test control group design. The subjects were randomized to two groups by preparing 30 lots. The lots were labelled as E which was assigned to Experimental group and C which was allocated to Conventional care group. The subjects were asked to pick a lot and based on that lot, the subjects were assigned to Experimental group and Conventional care group. The study was conducted in the Department of Radiation Oncology, Comprehensive Cancer Center at KMCH, Coimbatore. The sample size was 30 subjects. 15 subjects were assigned to each group. Non – Probability Purposive Sampling technique was adopted. Conceptual Framework was based on Modified Swanson’s Structure of Caring (1993). Cryotherapy was done by providing Ice cubes to the patient’s and instruct them to suck and rinse slowly and swish it around the mouth for 5 minutes and then spit it out. This was done 15 minutes before and after Radiation Therapy. Oral mucositis was assessed in both Experimental group and Conventional care group at the end of 1st, 2nd, 3rd, 4th, 5th and 6th week after Radiation Therapy using WHO Oral Mucositis Grading Scale and Patient – Reported Oral Mucositis Symptoms [PROMS] scale. Results: The Results of the study were by comparing the Oral Mucositis using WHO Oral Mucositis Scale at the end of each week between the Experimental group and Conventional care group, the ‘p’ value at the end of 2nd, 3rd, 4th and 5th week are 0.001, 0.05, <0.001 and 0.028 respectively and the p value for PROMS Scale is 0.022 which shows that there is a significant difference in Oral Mucositis Severity. Conclusion: In nutshell, the study recommends the use of cost effective Cryotherapy along with Soda – Bicarb mouth wash in Clinical Practice for patients who are receiving Head and Neck Radiation Therapy.

Photobiomodulation for chemotherapy-induced oral mucositis in leukemic children: A randomized controlled clinical trial.

Evaluation of the effectiveness of Photobiomodulation(PBM) for chemotherapy-induced oral mucositis (OM) in leukemic children. A randomized controlled clinical study including forty-four leukemic children diagnosed with chemotherapy-induced OM at the Hematology/Oncology inpatient unit at Alexandria University Children's Hospital, Alexandria, Egypt. Patients were randomly assigned to either the control or test groups with a 1:1 ratio. The control group received conventional symptomatic treatment, while the test group was treated with PBM in addition to the symptomatic treatment. The response to both treatment modalities was evaluated according to the reduction of pain and lesions severity from baseline to 5, 10, and 14days after treatment. A significant reduction of pain was recorded on day 10 in the test group compared to the control group (p<0.001). There was also a significant decline in the OM grades between the two groups on day14 (p=0.003). No adverse events were reported. The use of PBM along with the conventional treatment was effective in reducing pain and in the recovery of OM lesions in children receiving chemotherapy for the treatment of ALL. It was also safe and applicable to children.

Salivary inflammatory mediators as biomarkers for oral mucositis and oral mucosal dryness in cancer patients: A pilot study.

Oral mucositis (OM) is a common side effect in patients with cancer receiving chemotherapy and radiotherapy; however, no salivary mediator is known to be associated with OM. We aimed to determine candidate salivary inflammatory mediators potentially associated with OM in patients with cancer. To this end, we compared the relationships between OM grade, oral mucosal dryness, and inflammatory mediators (Interleukin (IL)-1β, IL-6, IL-10, IL-12p70, tumor necrosis factor (TNF), prostaglandin E2, and vascular endothelial growth factor) in patients with cancer and in healthy volunteers (HV). We collected saliva samples from 18 patients with cancer according to the following schedule: 1) within 14 days of treatment initiation, 2) within 3 days of OM occurrence, 3) when OM was improved or got worsened, and 4) within 7 days after chemotherapy completion. The oral care support team determined the OM grade at each sample collection point based on CTCAE version 5.0. Salivary inflammatory mediator concentrations were detected using cytometric bead array or enzyme-linked immunoassay. We compared oral mucosal dryness in pre- and post-index patients with cancer to that in HV (n = 33) using an oral moisture-checking device. Fourteen of eighteen patients experienced OM (four, grade 3 OM; four, grade 2 OM; six, grade 1 OM). IL-6, IL-10, and TNF salivary concentrations were significantly increased in the post-index group compared to those in the pre-index group (p = 0.0002, p = 0.0364, and p = 0.0160, respectively). Additionally, salivary IL-6, IL-10, and TNF levels were significantly higher in the post-index group than in the HV group (p < 0.0001, p < 0.05, and p < 0.05, respectively). Significant positive correlations were observed between OM grade and salivary IL-6, IL-10, and TNF levels (p = 0.0004, r = 0.4939; p = 0.0171, r = 0.3394; and p = 0007, r = 0.4662, respectively). Oral mucosal dryness was significantly higher in the HV than in the pre- and post-index groups (p < 0.001). Our findings suggest that salivary IL-6, IL-10, and TNF levels may be used as biomarkers for OM occurrence and grade in patients with cancer. Furthermore, monitoring oral mucosal dryness and managing oral hygiene before cancer treatment is essential.

Efficacy of GMI, a fungal immunomodulatory protein, for head and neck cancer patients with chemotherapy-related oral mucositis: An open-labeled prospective single-arm study.

Background:Cancer patients usually suffer from intensive chemotherapy-related oral mucositis (OM), yet limited effective treatment can rapidly alleviate OM severity.Methods:This prospective study examined the efficacy of Reishimmune-S containing one fungal immunomodulatory protein, GMI on OM in patients with head and neck cancer. Patients with head and neck cancer and the diagnosis of chemotherapy-related OM were enrolled randomizedly to receive standard supportive care with/without Reishimmune-S 500 mg/day orally for consecutive 14 days. Due to intolerance to standard supportive care alone in the control arm, only the experimental arm with Reishimmune-S supplementation was analyzed in our trial. OM grading was evaluated as the primary outcome on day 1, 8, and 15. Secondary outcomes were absolute neutrophil counts and quality of life assessed by the EORTC-QLQ-H&N 35 questionnaire on day 1, 8, and 15.Results:Reishimmune-S supplement significantly reduced OM grading both at day 8 and 15. Trouble with social contact and weight loss conditions were also improved by Reishimmune-S. Reishimmune-S did not significantly affect absolute neutrophil counts during the 15-day follow-up.Conclusion:Reishimmune-S supplement potentially alleviates the severity of chemotherapy-mediated OM.

ORAL MICROBIOME INFLUENCES THE CLINICAL COURSE OF ORAL MUCOSITIS IN ALLOGENEIC HSCT PATIENTS

<h3>Objectives</h3> Oral mucositis (OM) is a complex acute cytotoxicity of antineoplastic treatment that affects 40% to 85% of patients undergoing hematopoietic stem cell transplantation. Clinically, OM is characterized by redness or ulceration covered by a pseudomembrane of cellular debris and bacterial colonies that usually develops within 5 to 7 days after the conditioning drug's administration. Incidence of OM is associated with prolonged hospitalization, extensive analgesic pharmacotherapy, parenteral nutrition, and elevated treatment costs. In this context, the identification of patient risks for OM is fundamental to enhance supportive care in oncology. OM onset relies on mucosal microenvironment status, with a possible role of microbiota-driven inflammation. We aimed to investigate whether the oral mucosa microbiota was associated with the clinical course of OM. <h3>Study Design</h3> We collected oral mucosa samples from 30 patients undergoing allogeneic hematopoietic stem cell transplantation at preconditioning. During the period of the study, 13 of 30 patients developed OM. For those patients, additional oral mucosa samples were collected at OM ulceration onset and ulcerated OM healing. All samples were characterized by 16S rRNA sequencing. <h3>Results</h3> We observed that specific taxa were associated with OM risk, severity, and time to resolution. In particular, at preconditioning, higher relative abundance of <i>Lactococcus</i> was associated with an increased ulcerated OM risk (75% vs 33%; <i>P</i> = .034), and the relative abundance of <i>Porphyromonas</i> was positively correlated with ulcerated OM grade (rho = 0.605, <i>P</i> = .028). Additionally, we observed that higher relative abundance of <i>Solobacterium</i> at OM onset was associated with prolonged OM ulcerated duration (<i>P</i> = .0005), whereas higher relative abundance of <i>Lactobacillus</i> was associated with shortened ulcerated OM duration (<i>P</i> = .032). <h3>Conclusions</h3> This was the first study to investigate oral mucosa taxa as biomarkers for OM clinical course in patients undergoing allogeneic hematopoietic stem cell transplantation. Our findings suggest that further research should focus on evaluating the influence of host-microbiome interactions on OM pathophysiology.

Effects of a mobile oral care app on oral mucositis, pain, nutritional status, and quality of life in patients with head and neck cancer: A quasi-experimental study.

The aim of this work is to explore the effectiveness of a mobile app to support oral mucositis care to improve the nutritional status and reduce the occurrence of oral mucositis of patients with head and neck cancer undergoing concurrent chemoradiotherapy. Concurrent chemoradiotherapy is the optimal treatment for head and neck cancer, but oral mucositis and malnutrition are common complications. Quasi-experimental study using a pre-post design was used in this work. Participants were recruited from a major regional hospital in Taiwan from July 2018 to July 2020. There were 32 participants in each group: the mobile app group (Intervention Group) or routine care (Control Group). The primary outcome measure was Patient-Generated Subjective Global Assessment (PG-SGA). We also collected data on grade of oral mucositis, painNnumeric Rating Scale (NRS), weight loss, haemoglobin (Hb), albumin and quality of life (QoL). The PG-SGA score was significantly lower in the intervention than the control group at all three time points. Hb and albumin decreased less significantly in the intervention than the control group after 2 months. The oral mucositis grade was significantly less severe in the intervention than the control group at all three time points; for the NRS, at T2 and T3. Using the mobile app effectively improved nutritional status, alleviated the side effects, and improved the QoL of head and neck cancer patients with concurrent chemoradiotherapy.

Effectiveness of sodium bicarbonate and zinc chloride mouthwashes in the treatment of oral mucositis and quality of life in patients with cancer under chemotherapy.

AimThe purpose of the study is to evaluate the effectiveness of sodium bicarbonate and zinc chloride mouthwashes on oral mucositis and quality of life in patients undergoing chemotherapy.DesignThe present study was a randomized controlled trial study.MethodsOne hundred forty‐four patients with a cancer diagnosis were randomly assigned into three groups: sodium bicarbonate mouthwash (n = 48), zinc chloride mouthwash (n = 48) and placebo group (n = 48). The severity of mucositis and quality of life were examined blindly at the baseline and 3‐week follow‐up.ResultsThe grade of oral mucositis decreased at the end of the third weeks in the sodium bicarbonate and zinc chloride groups rather than the placebo group (p < .001). The severity of oral mucositis in the sodium bicarbonate and zinc chloride groups decreased from end of the first week until third week (p < .001). In addition, there was significant difference in the severity of oral mucositis among the groups at the end of the second (p = .014) and the third weeks (p < .001). Also, there was a statistically significant difference in quality of life scores between the sodium bicarbonate and zinc chloride mouthwash with the placebo group (p < .001).ConclusionZinc chloride and sodium bicarbonate mouthwashes were effective in treating and reducing the severity of oral mucositis, and subsequently improving quality of life in patients with cancer under chemotherapy. Therefore, we can recommend zinc chloride and sodium bicarbonate at the beginning of chemotherapy to improve oral health and promoting quality of life in these patients.

A randomized clinical trial of granulocyte macrophage colony stimulating factor mouthwash for oral mucositis in head and neck cancer.

Oral mucositis (OM) is a significant problem for patients with head and neck cancer (HNC). The purpose of this double-blind, randomized clinical trial (RCT) was to evaluate the effectiveness of the granulocyte macrophage colony stimulating factor (GM-CSF) mouthwash compared to Salt and Soda mouthwash for both the prevention (prior to onset of OM) and treatment (beginning at the onset of OM to its healing) of radiation therapy (RT)-induced OM. A total of 91 patients with HNC were randomized to receive: GM-CSF throughout both the prevention and treatment phases (GG group); Salt and Soda throughout both phases (SS group) or Salt and Soda during the prevention phase followed by GM-CSF at the onset of OM (SG group). Three groups were compared on the occurrence and grades of OM, functional status, pain, chewing, and swallowing during and after RT. No significant differences were found in the occurrence and grades of OM in the patients who used GM-CSF vs. Salt and Soda in the prevention phase. In addition, no differences were seen among the three groups in functional status, pain, chewing, and swallowing during and after RT. Given that GM-CSF was no more effective than Salt and Soda mouthwash for the prevention or treatment of OM, the readily available and cheaper mouthwash can be used at considerable cost savings.

Low level laser therapy versus benzydamin in prevention and treatment of oral mucositis induced by anticancer treatments (clinical and biochemical study)

Objective: In this study, patients undergoing neck and head radiotherapy (RT) with or with no chemotherapywere contrasted to the low-level laser therapy (LLLT) efficacy against benzydamine hydrochloride in treating andpreventing oral mucositis (OM) (CHT). Material and Methods: This study included 90 individuals with neckand head cancer who were undergoing radiotherapy (RT) individually or in mixture with chemotherapy (CHT),varying in age from 18 to 80 years. Three equal groups were randomly formulated: Group, I patients were usingoral care only, Group II patients were using benzydamine hydrochloride mouth rinse, and Group III patientswere medicated by using low-level laser therapy. The National Institute of Cancer-Common Toxicity Criteria(NIC-CTC) and the World Health Organization (WHO) were used to rate the severity of OM, and the pain wasvalidated utilizing a visual analog scale (VAS). The salivary level of tumor necrotic factor-a (TNF- a) was assayed. Results: As per WHO and NIC, the grade of oral mucositis at the end of cancer treatment was less in the LLLTgroup than in the other two groups. The alteration in TNF-a level was not significant. The laser group is moreliable to have less salivary levels of the pro-inflammatory cytokines TNF- a. Conclusion: The incidence of oralmucositis severity has seemed to be reduced due to the prophylactic use of benzydamine hydrochloride and lasertherapy protocols. However, laser therapy was more efficient in controlling the shape and progression of OM. KEYWORDSOral mucositis; Photobiomodulation; Radiation therapy; Chemotherapy; Low-level laser therapy; Benzydamine

Comparison of topical agents that are effective against oral mucositis associated with chemotherapy using a rat anticancer agent-induced oral mucositis model

ObjectiveStandard prophylactic or therapeutic treatments for oral mucositis (OM), a common adverse event of chemotherapy, have not been established. Therefore, we compared the efficacy of several potential drugs administered topically in a rat anticancer agent-induced OM model (ROMM). MethodsTen-week-old, female Sprague–Dawley rats (n = 196) were used to develop the ROMM; they were divided into seven groups—CT, SAS, TA, RM, SF, PZ, and TJ-14, which received distilled water (control), sodium azulene sulfonate hydrate, tranexamic acid, rebamipide, sucralfate hydrate, polaprezinc, and hangeshashinto, respectively. Body weight, OM grade, histopathology score, and intraoral bacterial count were determined at 6, 9, 11, and 16 days after inducing OM. ResultsThe body weight of each rat temporarily reduced in all groups. Nevertheless, the TJ-14 group showed a higher body weight than the CT group (p < 0.05) on day 16. The mean OM grade and histopathology score improved with time in the CT group. On days 11 and 16, the OM grade and histopathology score were lower in all drug groups than in the CT group, with a significant difference in the TJ-14 group (p = 0.0281 and 0.0035, respectively). On day 11, the PZ and TJ-14 groups presented lower intraoral bacterial counts than the CT group. On day 16, the RM, SF, PZ, and TJ-14 groups presented lower bacterial counts than the CT group (p < 0.01). ConclusionTJ-14, followed by PZ, has the greatest efficacy against chemotherapy-induced OM. Therefore, TJ-14 mouthwash is a potential supportive treatment during chemotherapy.

A real-world accuracy of oral mucositis grading in patients undergoing hematopoietic stem cell transplantation.

Oral mucositis is a common complication in patients undergoing hematopoietic stem cell transplantation. Accurate oral mucositis grading is essential for both clinical practice and oral mucositis research. This study aimed to evaluate the accuracy of daily oral mucositis grading by nurses in a tertiary hospital in Australia. A retrospective study was undertaken to review the daily patient oral assessment record, including diet, pain, erythema, ulceration and the oral mucositis grade based on World Health Organization (WHO) oral mucositis grading scale. The accuracy of the grade was determined by the observations recorded, and reasons for inaccuracy were documented. Any repetition of the same error in the same patient was noted. In total, 6841 oral assessments in 373 patients, conducted between 2017 and 2020, were reviewed. A total of 70% (N = 4781) were graded correctly. Of these, 64% (N = 3043) were grade 0. When the grade 0 scores were excluded, the accuracy of grading was reduced to 46% (N = 1738). Common reasons for incorrect grading included: unable to grade due to diet not specified, no ulceration and no pain was scored grade 1, no ulceration was scored as grade 2-4, oral intake was not taken into account, and pain without ulcer was scored 0. A total of 77% of the errors were repeated in the same patient on consecutive days. Our results suggest there is frequent inaccurate evaluation of oral mucositis and a need for nurse training to accurately assess oral mucositis.

Effectiveness of topically applied chamomile in the treatment of oral mucositis: a literature review

Oral mucositis (OM) is one of the main adverse events observed during the treatment of neoplasms, especially in relation to head and neck (H&amp;N) cancer. Complications, initially non-infectious of OM, can significantly compromise the chosen therapy, extend the hospitalization period and decrease the quality of life of patients with H&amp;N cancer. Therefore, the present work presents a narrative review that gathers, presents and discusses studies on the relationship between the topical application of chamomile-based pharmaceutical products and the treatment of oral mucositis, with an emphasis on its effectiveness. A literature search was conducted in August 2021 using PubMed, Scielo and LILACS. From literature search was identified 869 papers, of which 06 were selected to answer the guiding question of this study. Finally, it could be seen that chamomile has great potential to help manage OM, as well as other oral complications, especially in cases of patients undergoing H&amp;N cancer treatments using radiotherapy. Furthermore, formulations containing chamomile have been shown to be effective in slowing the progression of OM grades. However, it is necessary to evaluate in each formulation, the possible impacts of each pharmaceutical adjuvant, as well as the adverse events capable of increasing pharmacotherapeutic adherence.

Safety and efficacy of a mucoadhesive phytomedication containing curcuminoids and Bidens pilosa L. extract in the prevention and treatment of radiochemotherapy-induced oral mucositis: Triple-blind, randomized, placebo-controlled, clinical trial.

Oral mucositis (OM) is the significant complication of radio/chemotherapy treatment. This study evaluated the safety and efficacy of a mucoadhesive phytomedication containing curcuminoids and Bidens pilosa L. (FITOPROT) in the prevention/treatment of OM. Sixty-two patients were randomized into the group's intervention and placebo. Adverse effect assessment, OM grading, pain, and saliva collection were carried at the 1st, 15th, 21st, and final of radiotherapy (RT). Inflammatory salivary mediators were measured. FITOPROT decreased the severity of OM from the 15th to the final RT, while the placebo showed an increase in the severity (p < 0.05). Intervention group had a lower number of patients with ulcerated OM at the final RT (p < 0.05). Phytomedication prevented increases of IL-8 levels and reduced the salivary nitrite during RT. FITOPROT does not promote adverse effects, it appears to be effective at reducing the severity of OM, and it controls the concentration of pro-inflammatory mediators.

Radiobiological modeling of radiation-induced acute mucosal toxicity (oral mucositis and pharyngeal mucositis): A single-institutional study of head-and-neck carcinoma.

This study aimed to estimate the fitting parameters of sigmoidal dose-response (SDR) curve of radiation-induced acute oral and pharyngeal mucositis in head-and-neck (H and N) cancer patients treated with Intensity Modulated Radiation Therapy (IMRT) for the calculation of normal tissue complication probability (NTCP). Thirty H-and-N cancer patients were enrolled to model the SDR curve for oral and pharyngeal mucositis. The patients were evaluated weekly for acute radiation-induced (ARI) oral and pharyngeal mucositis toxicity, and their scoring was performed as per the common terminology criteria adverse events version 5.0. The radiobiological parameters, namely n, m, TD50, and γ50 were calculated from the fitted SDR curve obtained from the clinical data of H-and-N cancer patients. ARI toxicity for oral and pharyngeal mucosa in carcinoma of H-and-N cancer patients was calculated for the endpoint oral mucositis and pharyngeal mucositis. The n, m, TD50, and γ50 parameters from the SDR curve of Grade 1 and Grade 2 oral mucositis were found to be [0.10, 0.32, 12.35 ± 3.90 (confidence interval [CI] 95%) and 1.26] and [0.06, 0.33, 20.70 ± 6.95 (CI 95%) and 1.19] respectively. Similarly for pharyngeal mucositis, n, m, TD50, and γ50 parameters for Grade 1 and Grade 2 were found to be [0.07, 0.34, 15.93 ± 5.48 (CI. 95%) and 1.16 ] and [0.04, 0.25, 39.02 ± 9.98(CI. 95%) and 1.56] respectively. This study presents the fitting parameters for NTCP calculation of Grade 1 and Grade 2 ARI toxicity for the endpoint of oral and pharyngeal mucositis. The provided nomograms of volume versus complication and dose versus complication for different grades of oral mucositis and pharyngeal mucositis help radiation oncologists to decide the limiting dose to reduce the acute toxicities.

Neutrophil-to-Lymphocyte Ratio as a Factor Predicting Radiotherapy Induced Oral Mucositis in Head Neck Cancer Patients Treated with Radiotherapy.

Background: The objective of this research conducted in head and neck cancer (HNC) patients was the assessment of the relationship between neutrophil-to-lymphocyte ratio (NLR) and the incidence of severe radiotherapy (RT) induced oral mucositis (OM), as well as overall survival (OS). Methods: The study involved 207 patients in advanced stages (III–IV) of HNC. RTOG/EORTC scale was used to assess OM. The pre-treatment NLR was specified as the absolute neutrophil count divided by the absolute lymphocyte count. Results: Starting from second to seventh week of RT, we observed a significant, positive correlation between NLR values and OM grade. From the second to seventh week of RT, higher NLR values were related with significant increases (from 2- to over 24-fold) in the risk of occurrence of more severe OM (multivariate analysis confirmed its independent influence). Moreover, multivariate analysis for survival revealed that both higher TNM stage (HR = 1.84; p = 0.0043) and higher NLR values (HR = 1.48; p = 0.0395) were independent prognostic factors. Conclusion: NLR is a simple and accurate parameter that is useful in the evaluation of the risk of more severe OM, as well as an independent prognostic factor of OS in patients subjected to RT due to HNC.

Impact of LEAM and CBV conditioning on gastrointestinal toxicity at early periods following hematopoietic cell transplantation: A retrospective study

Objectives: To compare the severity of oral mucositis and the frequency of gastrointestinal mucositis, and to observe if there is impact of these adverse effects on overall survival (OS), in patients who underwent CBV (carmustine, BCNU, and VP-16) and LEAM (lomustine, etoposide, Ara-C, and melphalan) conditioning for autologous hematopoietic cell transplantation (aHCT). Method: We collected retrospective data from medical records (n = 120) of transplantation and mucositis in the digestive tract of Hodgkin’s and non-Hodgkin’s lymphoma patients. Results: The frequency of OM grade 1 was higher in LEAM (36.76%) than in CBV (19.72%, p=0.038). There were no significant differences between the frequency of gastrointestinal mucositis in the two regimens (CBV - 52.11% and LEAM - 63.27%, p=0.305). CBV regimen exhibited lower 1-year overall survival (OS) than did LEAM (p=0.003). Oral mucositis grade ≥2 was associated with reduced OS in the CBV group (p=0.013). CBV regimen (HR=2.98, p 0.005) and oral mucositis grade ≥2 (HR=2.17, p=0.013) interfered negatively on the OS rate. Conclusion: Oral mucositis was more severe in CBV than in LEAM, decreasing the OS rate. Further studies with comprehensive follow-up and toxicity analyses must be undertaken to clarify the safety of LEAM conditioning in the digestive tract.

Glutamine for prevention and alleviation of radiation-induced oral mucositis in patients with head and neck squamous cell cancer: Systematic review and meta-analysis of controlled trials.

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that investigated glutamine efficacy in preventing and alleviating radiation-induced oral mucositis (OM) among patients with head and neck (H&N) cancer. We screened five databases from inception till February 4, 2021 and followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We included 11 RCTs, comprising 922 patients (458 and 464 patients were assigned to glutamine and control group, respectively). The incidence and onset of radiation-induced OM of any grade did not substantially differ between both groups. However, glutamine substantially reduced the severity of radiation-induced OM, as reflected by the reduced incidence of severe OM and reduced mean maximal OM grade score. Additionally, glutamine significantly decreased the rates of analgesic opioid use, nasogastric tube feeding, and therapy interruptions. Oral glutamine supplementation demonstrated various therapeutic benefits in preventing and ameliorating radiation-induced OM among patients with H&N cancer.