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To evaluate the applicability of photobiomodulation therapy (PBM-T) in the management of xerostomia and OM. Fifty-three patients with head and neck squamous cell carcinoma were randomized into two groups: Sham and PBM-T. The Sham group received artificial saliva and laser simulation, while the PBM-T group received artificial saliva and PBM-T. Xerostomia-related quality of life (QoL), the presence or absence of OM lesions, the decayed-missing-filled teeth (DMFT) index, and periodontal charts were evaluated. The results of the QoL questionnaire, DMFT index, and periodontal chart were analyzed with the Kruskal–Wallis test, followed by the Student–Newman–Keuls test, while OM findings were compared using the Mann–Whitney test. QoL scores significantly increased in the Sham group (p < 0.0001), denoting more severe xerostomia symptoms (p = 0.0074), and decreased in the PBM-T group, indicating no or very mild xerostomia. Higher grades of OM were found in the Sham group than the PBM-T group (p = 0.0001). There was no significant difference in DMFT index or periodontal charts between the groups (p > 0.05). PBM-T improved QoL in patients with head and neck cancer treated with radiotherapy, whether as radiation alone or as an adjunct to chemotherapy and surgery.

Purpose Chemoradiotherapy (CRT)-induced oral mucositis (OM) adversely affects a patient’s oral functions and quality of life (QOL). Low-level laser therapy (LLLT) showed some preventive and curative effects against clinically reported objective measures of OM in few trials including our recently published study. There is dearth of evidence regarding the effects of LLLT on patient’s subjective experience of OM and QOL. Hence, we did this study to evaluate the effects of LLLT on a patient’s reported measures of OM and QOL in head and neck cancer (HNC) patients receiving CRT. Methods This triple blinded study randomized 220 HNC patients scheduled for CRT (three weekly Cisplatin + RT = 66 Gray (2 Gy/session), five fractions/week for 6.5 weeks, total 33 fractions) into laser (110) and placebo (110) groups. The laser group received LLLT (Technomed Electronics Advanced Laser Therapy 1000, He–Ne, λ  = 632.8 nm, power density = 24 mW/cm 2 , dosage = 3.0 J at each point, total dose/session = 36–40 J, spot size 1 cm 2 , irradiation time/point 125 s) before each radiation session, while the placebo group did not receive laser therapy. Methodology was similar to our recently published study (Gautam et al. Radiother Oncol 104:349–354, 2012 ). In this part of our study, a blinded assessor collected subjective outcomes of the patient’s reported measures of OM using Oral Mucositis Weekly Questionnaire-Head and Neck (OMWQ-HN) and QOL using Functional Assessment of Cancer Treatment-Head and Neck (FACT-HN) Questionnaire. Data were analyzed using repeated measure ANOVA through general linear model. Statistical significance was kept at p  < 0.05. Results Results analysis revealed that OMWQ-HN ( F  = 12.199, df  = 6,1314, p  < 0.001) and FACT-HN ( p  < 0.05) scores were significantly lower in LLLT than placebo group patients. Also, a significant reduction ( p  < 0.001) in incidence of severe OM, need for opioid analgesics, and total parenteral nutrition was observed. Conclusions LLLT was effective in improving the patient’s subjective experience of OM and QOL in HNC patients receiving CRT.

Background Recent preclinical and phase I studies have reported that rebamipide decreased the severity of chemoradiotherapy-induced oral mucositis in patients with oral cancer. This placebo-controlled randomized phase II study assessed the clinical benefit of rebamipide in reducing the incidence of severe chemoradiotherapy-induced oral mucositis in patients with head and neck cancer (HNC). Methods Patients aged 20–75 years with HNC who were scheduled to receive chemoradiotherapy were enrolled. Patients were randomized to receive rebamipide 2% liquid, rebamipide 4% liquid, or placebo. The primary endpoint was the incidence of grade ≥ 3 oral mucositis determined by clinical examination and assessed by central review according to the Common Terminology Criteria of Adverse Events version 3.0. Secondary endpoints were the time to onset of grade ≥ 3 oral mucositis and the incidence of functional impairment (grade ≥ 3) based on the evaluation by the Oral Mucositis Evaluation Committee. Results From April 2014 to August 2015, 97 patients with HNC were enrolled, of whom 94 received treatment. The incidence of grade ≥ 3 oral mucositis was 29% and 25% in the rebamipide 2% and 4% groups, respectively, compared with 39% in the placebo group. The proportion of patients who did not develop grade ≥ 3 oral mucositis by day 50 of treatment was 57.9% in the placebo group, whereas the proportion was 68.0% in the rebamipide 2% group and 71.3% in the rebamipide 4% group. The incidences of adverse events potentially related to the study drug were 16%, 26%, and 13% in the placebo, rebamipide 2%, and rebamipide 4% groups, respectively. There was no significant difference in treatment compliance among the groups. Conclusions The present phase II study suggests that mouth washing with rebamipide may be effective and safe for patients with HNC receiving chemoradiotherapy, and 4% liquid is the optimal dose of rebamipide. Trial registration ClinicalTrials.gov under the identifier NCT02085460 (the date of trial registration: March 11, 2014).

Background The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients who received POC to those who had not, and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE. Methods Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated for both the groups over 8 weeks by an oncologist. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months. Results There were no significant differences in PFS between the POC and Control Groups ( P  = 0.801). A BMI <  25 mg/m 2 and non-visceral metastasis were associated with longer PFS ( P  = 0.018 and P  = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS ( P  = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial. Conclusions POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI <  25 mg/m 2 , and who did not receive BMA while receiving EVE and EXE may have better prognoses. Trial registration The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov ( NCT02376985 ).

Background: Oral mucositis is a common and debilitating painful side effect of many forms of chemotherapy and radiation therapy. Mucositis may lead to dose reductions and unplanned interruptions of chemotherapy and/or radiotherapy (RT) and often affects patients' quality of life. Aim: The objective of the study was to assess the efficacy of the ayurvedic preparation in decreasing the severity of mucositis in head-and-neck cancer patients receiving concomitant chemoradiotherapy. Materials and Methods: In this prospective randomized study, the patients were divided into three groups. Group 1 patients received conventional mucositis treatment, whereas Group 2 patients received ayurvedic preparation Yashtimadhu in addition to conventional treatment. Group 3 patients received honey for local application in oral cavity as well as one tea spoon of honey twice daily orally in addition to routine conventional treatment. All the patients were assessed for mucositis at the end of every week during the RT for a period of 6 weeks. Results: A significant difference was observed between the groups at each time point. Nearly 42.85% of patients in conventional treatment arm developed Grade 3 mucositis, 20% of patients developed Grade 3 mucositis in group where honey was given, and only 15.5% of patients developed Grade 3 mucositis in Yastimadhu group. Unplanned treatment breaks and hospitalization of patients were reduced with the use of yashtimadhu as compared to other two groups. Conclusion: Yashtimadhu was observed to be effective and delayed the development of severe form of mucositis. The drug appeared to be more efficient in the management of radiation-induced mucositis.

Oral mucositis (OM) is the most common debilitating complication among patients undergoing hematopoietic stem cell transplantation (HSCT). Photobiomodulation therapy (PBM) has shown beneficial effects in the treatment of OM, but few studies have evaluated its biological effects. This study evaluated the effect of PBM on the reduction of OM severity in patients undergoing HSCT and its relation to the modulation of the inflammatory response. Fifty-one patients were randomly assigned to two groups: PBM [submitted to PBM from admission (AD) to D+7] ( n  = 27) and control ( n  = 24) [received oral hygiene]. OM severity was assessed daily using the WHO scale. Saliva samples were collected on AD, D+7, and hospital discharge (HD) to measure CXCL8/interleukin 8, using cytometric bead array analysis and nitrite (NO) and myeloperoxidase (MPO) using colorimetric methods. PBM significantly reduced the severity of OM from D+7 to D+11 ( p  < 0.05). All non-interventional patients (controls) who developed grade 2 or higher OM induced an increase of CXCL8 in saliva ( n  = 14) on D+7. PBM led to a decrease in CXCL8 on D+7 in 85% of patients, while 70.8% of patients in the control group presented an increase in this chemokine ( p  = 0.007). NO decreased from AD to D+7 in the PBM group ( p  > 0.05). MPO significantly decreased on D+7 in both groups ( p  < 0.05). PBM brought about a reduction in the severity of OM in patients undergoing HSCT, and this reduction was associated with a decrease in CXCL8 salivary levels.

Aim This retrospective analysis focused on the effect of treatment with EVE/EXE in a real-world population outside of clinical trials. We examined the efficacy of this combination in terms of PFS and RR related to dose intensity (5 mg daily versus 10 mg daily) and tolerability. Methods 163 HER2-negative ER+/PgR+ ABC patients, treated with EVE/EXE from May 2011 to March 2016, were included in the analysis. The primary endpoints were the correlation between the daily dose and RR and PFS, as well as an evaluation of the tolerability of the combination. Secondary endpoints were RR, PFS, and OS according to the line of treatment. Patients were classified into three different groups, each with a different dose intensity of everolimus (A, B, C). Results RR was 29.8% (A), 27.8% (B) ( p  = 0.953), and not evaluable (C). PFS was 9 months (95% CI 7–11) (A), 10 months (95% CI 9–11) (B), and 5 months (95% CI 2–8) (C), p  = 0.956. OS was 38 months (95% CI 24–38) (A), median not reached (B), and 13 months (95% CI 10–25) (C), p  = 0.002. Adverse events were stomatitis 57.7% (11.0% grade 3–4), asthenia 46.0% (6.1% grade 3–4), hypercholesterolemia 46.0% (0.6% grade 3–4), and hyperglycemia 35.6% (5.5% grade 3–4). The main reason for discontinuation/interruption was grade 2–3 stomatitis. Conclusions No correlation was found between dose intensity (5 vs. 10 mg labeled dose) and efficacy in terms of RR and PFS. The tolerability of the higher dose was poor in our experience, although this had no impact on efficacy.

Purpose Combining the mTOR inhibitor ridaforolimus and the anti-IGFR antibody dalotuzumab demonstrated antitumor activity, including partial responses, in estrogen receptor (ER)-positive advanced breast cancer, especially in high proliferation tumors (Ki67 > 15%). Methods This randomized, multicenter, international, phase II study enrolled postmenopausal women with advanced ER-positive breast cancer previously treated with a nonsteroidal aromatase inhibitor (NCT01234857). Patients were randomized to either oral ridaforolimus 30 mg daily for 5 of 7 days (once daily [qd] × 5 days/week) plus intravenous dalotuzumab 10 mg/kg/week or oral exemestane 25 mg/day, and stratified by Ki67 status. Due to a high incidence of stomatitis in the ridaforolimus–dalotuzumab group, two sequential, nonrandomized, reduced-dose cohorts were explored with ridaforolimus 20 and 10 mg qd × 5 days/week. The primary endpoint was progression-free survival (PFS). Results Median PFS was 21.4 weeks for ridaforolimus 30 mg qd × 5 days/week plus dalotuzumab 10 mg/kg ( n  = 29) and 24.3 weeks for exemestane ( n  = 33; hazard ratio = 1.00; P  = 0.5). Overall survival and objective response rates were similar between treatment arms. The incidence of drug-related, nonserious, and serious adverse events was higher with ridaforolimus/dalotuzumab (any ridaforolimus dose) than with exemestane. Lowering the ridaforolimus dose reduced the incidence of grade 3 stomatitis, but overall toxicity remained higher than acceptable at all doses without improved efficacy. Conclusions The combination of ridaforolimus plus dalotuzumab was no more effective than exemestane in patients with advanced ER-positive breast cancer, and the incidence of adverse events was higher. Therefore, the combination is not being further pursued.

Purpose This randomised, placebo-controlled single-blind trial investigated the safety and efficacy of SAMITAL®, a formulation of highly standardised botanical extracts, in the treatment of chemo/radiotherapy-induced oral mucositis (OM) in patients with head and neck cancer. Methods Patients received SAMITAL® or placebo four times daily for up to 50 days during scheduled chemo/radiotherapy. Severity of OM was monitored according to a modified WHO severity scale, and pain and quality-of-life assessments were based on the effect of symptoms of OM on relevant daily activities, according to a visual analogue scale. Results Mean scores for the severity of OM were significantly ( p  < 0.05 versus baseline) reduced from day 31 until the end of treatment in patients treated with SAMITAL® ( n  = 20). No significant improvement was observed in the placebo group ( n  = 10). Pain reduction was significant from day 4 till end of treatment with SAMITAL® and from days 7 to 21 in placebo patients. SAMITAL® also significantly improved quality of life, as shown by improvements in scores for relevant daily activities including eating, drinking and sleeping. All SAMITAL® patients completed the treatment period, but no placebo recipients completed treatment. No severe adverse events were observed with SAMITAL®, and systemic absorption of relevant active ingredients was undetectable. Conclusions SAMITAL® significantly decreased the severity of chemo/radiotherapy-induced OM in patients with head and neck cancer, with no treatment-related adverse events. Pain relief lasted through the treatment period, and improvements in quality of life were reflected by the significant benefits of SAMITAL® on activities like drinking, eating and speaking.