Project description:IntroductionHangeshashinto has been employed for oral mucositis prevention in patients receiving cancer treatment, but the evidence has not been sufficiently robust to guide clinical decision-making. This study will therefore be undertaken to assess the effectiveness of Hangeshashinto for preventing oral mucositis in patients with cancer who are receiving treatment.Methods and analysisThe databases will include PubMed, Embase, the Cochrane Library, Chinese databases and Japanese databases. The literature will be searched from the databases' inception until May 2021. Other sources, such as potential grey literature, reference lists from included studies and relevant systematic reviews and conference papers, will also be searched. The primary outcome is the incidence of mucositis of any severity, and the secondary outcomes are interruptions to cancer treatment, oral pain and nutritional status. The risk of bias of eligible studies will be assessed using the Cochrane Collaboration's 'risk of bias' tool. Both the Q test and I2 statistic will be performed to assess statistical heterogeneity. If I2 >50%, sensitivity and subgroup analysis will be conducted. The quality of evidence will be rated according to the Grading of Recommendations, Assessment, Development and Evaluation approach. Egger's test will be used to assess reporting bias.Ethics and disseminationThis systematic review will evaluate only published data; therefore, ethical approval is not required.Prospero registration numberCRD42020216145.
Project description:This paper investigates the occurrence of severe oral mucositis and associated factors in blood and solid cancer pediatric patients subjected to cancer treatment, using a survival analysis. A longitudinal, descriptive, observational and inductive study of 142 pediatric patients aged from 0 to 19 years was conducted from 2013 to 2017. Data were collected using a form to record the sociodemographic characteristics and health-related aspects of patients and the modified Oral Assessment Guide (OAG). Survival analysis was performed using the Kaplan-Meier method and Cox semiparametric model. The median times to occurrence of severe oral mucositis were 35.3 and 77.1 days for patients with hematologic malignancies and solid tumors, respectively. The Cox model showed that white cell changes and platelet counts as well as the use of natural chemotherapeutic agents are risk factors for the occurrence of oral mucositis among patients with hematologic malignancies. Nonetheless, among patients with solid tumors, the occurrence of oral mucositis was associated with female sex, mixed ethnicity, the presence of metastasis, abnormal creatinine levels, a combination of chemotherapy, radiotherapy, and surgery, and the administration of chemotherapeutic agents included in the miscellaneous group. The time to occurrence of severe oral mucositis and its associated factors varied according to cancer type.
Project description:OBJECTIVE:To estimate the efficacy of traditional Chinese medicine (Chining decoction, CHIN) for radiation-induced oral mucositis in patients with head and neck cancer. METHODS:From May 2014 to December 2015, 70 consecutive patients were randomly assigned to receive CHIN (treatment group) or recombinant human epidermal growth factor (rhEGF) spray (control group) at a 1:1 ratio. CHIN was administered to treatment group from the first day of radiotherapy until the completion of radiotherapy. Simultaneously, the rhEGF spray was administered to control group on the oral mucosa of irradiated area. The clinical benefit was determined by gradation of mucositis (Common Terminology Criteria for Adverse Events v4.0), oral pain, and xerostomia (visual analysis scale) for each week during radiotherapy. Body mass index was evaluated before and after radiotherapy. RESULTS:Patients in the treatment group had prominent remission of oral pain and grade of mucositis on each observing point compared with those in control group ( P < .01). Xerostomia was decreased notably in treatment group compared with control group ( P < .01). Body mass index in the treatment group exhibited advantage over control group after radiotherapy, but there was no statistical significance (19.8 ± 3.26 vs 18.8 ± 2.5 kg/m2, P = .153, >.05). CONCLUSIONS:CHIN presented an obvious advantage in preventing radiation-induced oral mucositis compared with rhEGF spray.
Project description:Mucositis is an acute inflammation of the oral mucosa because of radiotherapy and/or chemotherapy. All patients receiving radiotherapy in the head and neck region develop oral mucositis. The aim of this study was to analyse the effects of selective oral flora elimination on radiotherapy-induced oral mucositis, in a double-blind, randomised, placebo-controlled trial. Sixty-five patients with a malignant tumour in the head and neck regions to be treated with primary curative or postoperative radiotherapy participated in this study. The patients received either the active lozenges of 1 g containing polymyxin E 2 mg, tobramycin 1.8 mg and amphotericin B 10 mg (PTA) (33 patients) or the placebo lozenges (32 patients), four times daily during the full course of radiotherapy. Mucositis, changes in the oral flora, quality of feeding and changes of total body weight were assessed. Mucositis score did not differ between the groups during the first 5 weeks of radiotherapy. Nasogastric tube feeding was needed in six patients (19%) of the placebo group and two patients (6%) of the PTA group (P=0.08). Mean weight loss after 5 weeks of radiation was less in the PTA group (1.3 kg) (s.d.: 3.0) than in the placebo group (2.8 kg) (s.d.: 2.9) (P=0.05). Colonisation index of Candida species and Gram-negative bacilli was reduced in the PTA group and not in the placebo group (P<0.05). No effect on other microorganisms was detected. In conclusion, selective oral flora elimination in head and neck irradiation patients does not prevent the development of severe mucositis.
Project description:Mucositis is a significant complication of intensive chemotherapy or hematopoietic cell transplantation (HCT), with few treatment options. Ketamine mouthwashes have been used for pain relief, but supporting evidence is limited. The primary objective of this study was to assess the reduction in pain intensity of stomatodynia and odynophagia compared to baseline assessment.This open-label, prospective, phase II interventional study (NCT01566448) was conducted from February 2012 through July 2015. Patients with grade 3 or 4 oral mucositis according to the World Health Organization (WHO) scale as a result of chemotherapy were treated with ketamine mouthwash 20 mg/5 mL four times daily and every 4 h as needed.Thirty patients were enrolled and a total of 136 assessments were conducted. A statistically significant reduction in pain scores of 2 and 3 points was achieved after 1 h and 3 days, respectively (p < 0.0001, p = 0.0003). Pain scores were significantly improved while swallowing, reduced 1 and 4 points at 1-h and 3-day assessment, respectively (p = 0.0006, p = 0.0001). No patients developed adverse effects related to ketamine administration.Ketamine mouthwashes resulted in clinically meaningful and statistically significant reduction in pain scores, have an acceptable safety profile, and can be a useful adjunctive treatment in the multi-modal management of severe mucositis.
Project description:BackgroundA complete understanding of oral mucositis (OM) is crucial to develop appropriate interventions to aid in the successful overall health outcome of paediatric patients undergoing haematopoietic stem cell transplantation (HSCT).AimsThis study aimed at determining the prevalence and severity of OM and at identifying the predictive factors that might aggravate OM at one-week, two-week and three-week post-HSCT.MethodsThis retrospective, hospital-based study reviewed the medical records of 170 paediatric patients, summarising the patients' characteristics using descriptive statistics. Binary logistic regression was used to identify factors associated with the development of OM.ResultsAt one-week post-HSCT, 41% of 140 patients (n = 49) had developed OM, this was reduced at two-week (n = 36, 33%) and three-week (n = 13, 19%) post-HSCT. Univariate logistic regression revealed that patients with cancer (OR = 0.16, 95% CI = 0.05-0.54; p-value = .003) had a significantly lower prevalence of OM. Younger patients with an average age of 7.9 years old (OR = 0.85, 95% CI = 0.75-0.97; p-value = 0.013) and the presence of GvHD (OR = 2.37, 95% CI = 1.03-5.45, p-value = 0.042) were significantly related to a higher prevalence of OM. Multivariable logistic regression confirmed that the risk of OM is lower in patients with cancer compared to those with immunodeficiency syndromes or hereditary blood diseases (OR = 0.18, 95% CI = 0.04-0.77; p-value = .021).ConclusionsThis study identified a significantly lower prevalence of OM in patients with cancer compared to other conditions and that young recipients and those who developed GvHD were more likely to have OM.
Project description:In addition to disease diagnostics, there is a need for biomarkers to predict severity of cancer therapy side effects such as oral mucositis. Oral mucositis is an inflammatory lesion of oral mucosa caused by high-dose chemotherapy and/or radiation that is especially prevalent during oral cancer treatment. We describe here a semi-automated, modular microfluidic immunoarray optimized for ultrasensitive detection of pro-inflammatory cytokines involved in pathobiology of oral mucositis. Our goal is to methodologically identify risk of mucositis early in oral cancer treatment, before the onset of lesions. Biomarkers include tumor necrosis factor alpha (TNF-?), interleukin-6 (IL-6), interleukin-1? (IL-1?), and C-reactive protein (CRP). Protein analytes were captured from serum in a capture chamber by 1-?m magnetic beads coated with antibodies and enzyme labels. Beads are then transported downstream to a detection chamber containing an eight-sensor array coated with glutathione-coated gold nanoparticles (GSH-AuNP) and a second set of antibodies to capture the beads with analyte proteins. In this first application of the immunoarray to four-protein multiplexed measurements, ultralow detection limits of 10-40 fg mL(-1) in 5 ?L serum were achieved for simultaneous detection in 30 min. Mass detection limits were 2.5-10 zmol, as few as 1500 molecules. Accuracy and diagnostic utility of the arrays were demonstrated by correlation of levels of the four biomarker proteins in serum from head and neck cancer patients with results from standard ELISA. This approach may lead to rapid, low-cost estimates of projected risk for severity of oral mucositis in cancer patients to enable improved therapeutic management.
Project description:Oral mucositis affects more than three-fourths of patients undergoing chemotherapy and represents a significant burden to patients and caregivers. Lesions develop as a result of chemotherapeutic agents attacking the rapidly dividing cells of the gastrointestinal tract. Severity can range from mild, painless tissue changes to bleeding ulcerations that prevent oral intake and require narcotic pain relievers. Oral mucositis also leads to an increased risk of infection and can often delay further chemotherapy treatment. A number of assessment scales have been developed to better qualify the symptoms associated with this condition. Few pharmacologic agents have been approved to either prevent the development or alleviate the symptoms of oral mucositis. Current options include the use of antimicrobial mouthwashes, amino acid rinses, and topical healing agents. Palifermin, a keratinocyte growth factor, may be a future option after its use in children is explored. With achievements in other areas of supportive care in patients undergoing chemotherapy, oral mucositis should represent the forefront of new research. This review will provide a comprehensive examination of available options for children who have oral mucositis.
Project description:PurposeTo develop an evidence-based clinical practice guideline for the prevention of oral mucositis in children (0-18?years) receiving treatment for cancer or undergoing haematopoietic stem cell transplantation (HSCT).MethodsThe Mucositis Prevention Guideline Development Group was interdisciplinary and included internationally recognised experts in paediatric mucositis. For the evidence review, we included randomised controlled trials (RCTs) conducted in either children or adults evaluating the following interventions selected according to prespecified criteria: cryotherapy, low level light therapy (LLLT) and keratinocyte growth factor (KGF). We also examined RCTs of any intervention conducted in children. For all systematic reviews, we synthesised the occurrence of severe oral mucositis. The Grades of Recommendation, Assessment, Development and Evaluation approach was used to describe quality of evidence and strength of recommendations.ResultsWe suggest cryotherapy or LLLT may be offered to cooperative children receiving chemotherapy or HSCT conditioning with regimens associated with a high rate of mucositis. We also suggest KGF may be offered to children receiving HSCT conditioning with regimens associated with a high rate of severe mucositis. However, KGF use merits caution as there is a lack of efficacy and toxicity data in children, and a lack of long-term follow-up data in paediatric cancers. No other interventions were recommended for oral mucositis prevention in children.ConclusionsAll three specific interventions evaluated in this clinical practice guideline were associated with a weak recommendation for use. There may be important organisational and cost barriers to the adoption of LLLT and KGF. Considerations for implementation and key research gaps are highlighted.
Project description:Background: Trastuzumab is associated with the risk of cardiotoxicity. Here, we aim to explore interventions for preventing trastuzumab-related cardiotoxic effects in breast cancer patients. Methods: A systematic review was performed including trials of breast cancer patients with intervention to prevent cardiotoxicity of trastuzumab. Trials were searched through databases including PubMed, Embase, and Cochrane Library. Results: Eight RCTs were included. Five trials reported the outcomes of short-duration interventions, including 6-month and 9-week durations, and only 9-week treatment has a significant difference from the 12-month group (OR 0.38; 95% CI 0.18-0.83) using cardiotoxicity as the outcome. However, 6-month treatment turned out to yield less occurrence of trastuzumab discontinuation (OR 0.32; 95% CI 0.24-0.42). Three trials reported interventions of cardioprotective drugs, and there is no significant difference shown in any cardioprotective group compared with placebo (cardiotoxicity outcome: angiotensin-converting enzyme inhibitor: OR 0.48; 95% CI 0.057-2.3; angiotensin receptor blocker: OR 1.3; 95% CI 0.12-14; β-blocker: OR 0.48; 95% CI 0.057-2.3; trastuzumab interruption outcome: angiotensin-converting enzyme inhibitor: OR 0.45; 95% CI 0.12-1.3; angiotensin receptor blocker: OR 0.87; 95% CI 0.15-4.8; β-blocker: OR 0.41; 95% CI 0.11-1.2). Conclusion: Only the 9-week group has a significant difference from the 12-month group using cardiotoxicity as the outcome. And 6-month treatment turned out to yield less occurrence of trastuzumab discontinuation. The use of cardioprotective drugs failed to prevent trastuzumab-related cardiotoxic effects in breast cancer patients.