Background: Cachexia worsens prognosis, quality of life and chemotherapy treatment compliance of patients with lung cancer. Chemotherapy-induced cachexia has also been implicated in lowered mortality. This study aimed to evaluate the frequency of cachexia-related measures and symptoms as outcomes in lung cancer chemotherapy trial protocols and to examine how key trial characteristics influence them. Method: We conducted a cross-sectional data analysis of randomised controlled chemotherapy trials of lung cancer registered in four public trial registries between 2012 and 2023. Trial outcome measures included overall survival, treatment toxicity/side effects and cachexia-related indicators such as physical activity, weight/body mass index (BMI), dietary limitations, caloric intake and lean muscle mass. Symptom-related outcomes, including appetite loss, diarrhoea, pain, fatigue/insomnia, constipation, nausea, vomiting, dysphagia, dyspnoea and oral mucositis, were also extracted. Additionally, the number and type of performance status and assessment tool were recorded. Data were summarised descriptively. Chi-square tests were used to examine associations between trial outcomes and characteristics including cancer type, trial location, lead investigator/funding source, assessment tools and trial commencement year. Ap< 0.05 was considered statistically significance. Results: Of the 335 trial protocols (non-small cell (87.2%) and small cell (12.8%)), most were from Europe (50.4%). The trial lead investigator was from industry (56.7%) followed by academia (25.1%). Allied health professional involvement was minimal (0.6%). Trial protocols mostly recorded overall survival (96.4%) and toxicity (83.9%). However, physical activity, weight/BMI, dysphagia, dyspnoea and oral mucositis were recorded in <30%, with dietary limitations, caloric intake and lean muscle mass recorded in <3% of the trials. Measures and symptoms were not associated with cancer type. Trial location was associated with the measures toxicity, physical activity and caloric intake and all symptoms. Lead investigator was associated with the measures toxicity and weight/BMI and all symptoms except for dyspnoea. Performance status and assessment tools were mentioned in 93.4% and 41.8% of the trials, respectively, with significant associations between assessment tools and outcomes, except for weight/BMI, dietary limitations, lean muscle mass, dysphagia and oral mucositis. There was a significant trend with trial commencement year for the measures physical activity (p= 0.002) and weight/BMI (p= 0.000) and all symptoms, except for appetite loss (p= 0.115) and pain (p= 0.433). Conclusions: While the reporting of measures and outcomes was generally higher compared to gastrointestinal chemotherapy cancer trials, it still faced significant under-reporting. Assessment tools should include cachexia-specific symptoms to accurately assess the quality of life in patients with lung cancer undergoing chemotherapy clinical trials.
背景：恶病质会恶化肺癌患者的预后、生活质量及化疗依从性。化疗诱导的恶病质也与死亡率升高相关。本研究旨在评估肺癌化疗试验方案中恶病质相关指标与症状作为结局指标的记录频率，并探讨关键试验特征对其影响。方法：我们对2012年至2023年间在四个公共试验注册平台注册的肺癌随机对照化疗试验进行了横断面数据分析。试验结局指标包括总生存期、治疗毒性/副作用以及恶病质相关指标（如体力活动、体重/体重指数、饮食限制、热量摄入和瘦体质量）。同时提取症状相关结局指标，包括食欲减退、腹泻、疼痛、疲劳/失眠、便秘、恶心、呕吐、吞咽困难、呼吸困难和口腔黏膜炎。此外，还记录了体能状态的数量与类型及评估工具。采用描述性统计汇总数据，运用卡方检验分析试验结局与癌症类型、试验地点、主要研究者/资金来源、评估工具及试验起始年份等特征间的关联性，以p<0.05为统计学显著性标准。结果：在335项试验方案中（非小细胞肺癌占87.2%，小细胞肺癌占12.8%），多数试验来自欧洲（50.4%）。主要研究者来自企业（56.7%）和学术界（25.1%），专职医疗人员参与度极低（0.6%）。试验方案普遍记录总生存期（96.4%）和毒性反应（83.9%），但体力活动、体重/体重指数、吞咽困难、呼吸困难和口腔黏膜炎的记录率低于30%，饮食限制、热量摄入和瘦体质量记录率不足3%。各项指标与症状均与癌症类型无显著关联。试验地点与毒性反应、体力活动、热量摄入指标及所有症状存在关联；主要研究者来源与毒性反应、体重/体重指数指标及除呼吸困难外的所有症状存在关联。93.4%和41.8%的试验分别提及体能状态和评估工具，除体重/体重指数、饮食限制、瘦体质量、吞咽困难和口腔黏膜炎外，评估工具与结局指标存在显著关联。试验起始年份与体力活动（p=0.002）、体重/体重指数（p=0.000）指标及除食欲减退（p=0.115）和疼痛（p=0.433）外的所有症状呈现显著时间趋势。结论：尽管与胃肠道癌症化疗试验相比，本研究中指标与结局的报告率总体较高，但仍存在显著漏报现象。评估工具应纳入恶病质特异性症状，以准确评估接受化疗临床试验的肺癌患者生活质量。
What Cachexia-Related Outcomes Are Measured in Lung Cancer Chemotherapy Clinical Trials?
肿瘤(癌症)患者之家