Preventive effect and safety of Chinese herbal medicine for oral mucositis during radiotherapy in patients with head and neck cancer: Study protocol for a randomized trial.

Background: Oral mucositis (OM) is a common side effect of radiotherapy (RT) that can have severe implications in patients with head and neck cancer (HNC). Traditional Chinese medicine (TCM) formula is widely applied in treating OM, but little substantial evidence exists to clarify it effects. The study intends to determine whether the TCM-based prescription in treating HNC with RT can improve the OM when compared with RT alone. Methods: A single-center, randomized, two-arm parallel-group, open-label controlled clinical trial will be conducted to determine whether the Zi-Yin-Liang-Ge-San (ZYLGS), which contains Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis, combined with RT can improve the incidence and severity of OM. Two hundred participants will randomly 1:1 to receive at least 6 weeks of RT plus ZYLGS powder or control. The primary outcome measures are onset, gradation of OM (Common Terminology Criteria for Adverse Events v5.0), and oral pain (visual analogue scale). The secondary outcome measures include nutritional status, the EORTC Quality of Life Core Questionnaire and head and neck module. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, serious adverse events, and blood and biochemical analysis will be recorded to evaluate the safety. Visits will be performed for each week during the RT treatment period and then 2 weeks in the follow-up period. Discussion: The study's result will provide a high-level evidence for TCM-based formulation for HNC patients with RT on the effect of OM prevention and management.

Concurrent chemoradiotherapy by simultaneously integrated boost volumetric-modulated arc therapy for nasopharyngeal carcinoma-toxicity/quality of life and survival.

BACKGROUND: To investigate the toxicity, changes of quality of life (QOL), and survival for patients with nasopharyngeal cancer (NPC) treated by concurrent chemoradiotherapy (CCRT) with simultaneously integrated boost volumetric-modulated arc therapy (SIB-VMAT). METHODS: A total of 68 NPC patients treated by CCRT with SIB-VMAT technique were collected. QOL was longitudinally assessed by the EORTC QLQ-C30 and HN35 questionnaires at the 4 time points: baseline, 42.4 Gy (20 fractions), and 3, 12 months after CCRT. RESULTS: The 4-year locoregional relapse free, distant metastasis free, failure free, and overall survival rates were 97.0%, 86.4%, 82.0%, and 88.1%, respectively. The 4-year cumulative incidence rate of late toxicities with grade 3 or more was 3.0%. One year after CCRT, most QOL scales, except some oral related symptoms, recovered to baseline level. CONCLUSION: CCRT with SIB-VMAT produces excellent locoregional control, few severe late toxicity, and good general health status for NPC patients.

Screening for Psychologic Distress in Taiwanese Cancer Inpatients Using the National Comprehensive Cancer Network Distress Thermometer: The Effects of Patients' Sex and Chemotherapy Experience.

BACKGROUND: Patients with cancer often experience distress, and early detection and management of psychologic distress are vital for improving patients' outcomes. OBJECTIVE: This study investigates the validity and determines the optimal cutoff score-for clinically significant distress-for the Taiwanese Distress Thermometer (DT). METHODS: This study consisted of 768 inpatients diagnosed with cancer in a general hospital in southern Taiwan. The condition of psychologic distress was assessed in these patients using the DT and Chinese Health Questionnaire-12. We applied a receiver operating characteristic curve analysis to evaluate the discriminative validity of the DT, adopting the Chinese Health Questionnaire-12 score of ≥4 as having psychologic distress. We also used a logistic regression model to determine the associated factors of the concordant screening results of both the DT and the Chinese Health Questionnaire-12. RESULTS: The DT demonstrated an acceptable validity of discriminating between patients with psychologic distress and those without (area under curve = 0.787). We found a DT score of 4 to be the best cutoff value, with a 72.2% of sensitivity, a specificity of 80.0%, and an accuracy of 79.2%. The concurrence between the DT and the Chinese Health Questionnaire-12 was related to patients' sex and chemotherapy treatment experience. CONCLUSION: Our findings show that the DT has acceptable psychometric properties for identifying psychologic distress in patients with cancer. However, the optimal cutoff point of the DT may vary with patients' characteristics.

Pre-treatment maximal oesophageal wall thickness is independently associated with response to chemoradiotherapy in patients with T3-4 oesophageal squamous cell carcinoma.

OBJECTIVES: Combined chemoradiotherapy with or without surgery is frequently performed as a curative treatment in patients with T3-4 locally advanced oesophageal squamous cell carcinoma. Computed tomography (CT) is frequently performed before and after chemoradiotherapy. The aim of this study is to evaluate the utility of the oesophageal wall thickness on CT scans to predict the response to chemoradiotherapy and the treatment outcome in patients with T3-4 locally advanced oesophageal squamous cell carcinoma. METHODS: Ninety-six patients with T3-4 locally advanced oesophageal squamous cell carcinoma, who were treated with neoadjuvant chemoradiotherapy followed by surgery between 1998 and 2008 at the Kaohsiung Chang Gung Memorial Hospital, were retrospectively reviewed. CT scans before and after chemoradiotherapy were available for 93 patients. Of these 93 patients, 24% (22 of 93) achieved a pathologically complete response (pCR). The measurement of the maximal dimension of the oesophageal wall thickness on CT scans before (pre) and after (post) chemoradiotherapy was performed retrospectively, and correlated with the response to chemoradiotherapy and patients' outcome. The percentage decrease of maximal oesophageal wall thickness after chemoradiotherapy was determined by the formula: [(pre -post)/pre] 100. RESULTS: Pre- and post-chemoradiotherapy maximal oesophageal wall thicknesses were significantly correlated with pCR, but the percent decrease of oesophageal wall thickness after chemoradiothrapy was not. Logistic models showed that pre-chemoradiotherapy maximal oesophageal wall thickness ≥20 mm was independently associated with response to chemoradiotherapy. For patients with pre-chemoradiotherapy maximal oesophageal wall thickness ≥20 mm, 91% did not achieve pCR after chemoradiotherapy. Univariate analyses demonstrated that a pre-chemoradiotherapy maximal oesophageal wall thickness ≥20 mm, T4 disease and positive regional lymph nodes (N stage) were predictive of inferior disease-free survival. In a multivariate comparison, pre-chemoradiotherapy maximal oesophageal wall thickness ≥20 mm represented an independent adverse prognosticator for disease-specific survival and disease-free survival. CONCLUSIONS: Most of the T3-4 locally advanced oesophageal squamous cell carcinoma patients with pre-treatment maximal oesophageal wall thickness ≥20 mm did not achieve pCR after chemoradiotherapy. Thus, oesophgectomy may be considered in advance in this group of patients. Pre-treatment maximal oesophageal wall thickness is of independent prognostic value in patients with T3-4 locally advanced oesophageal squamous cell carcinoma who receive neoadjuvant chemotheradiotherapy.