Razmovski-Naumovski Valentina, Tanous Anthony, Valaire Ross
School of Medicine, Western Sydney University (WSU), Sydney, NSW 2560, Australia.
South West Sydney Clinical Campuses, Faculty of Medicine & Health, University of New South Wales (UNSW) Sydney, Sydney, NSW 2170, Australia.
Cancers (Basel). 2025 Jul 11;17(14):2309. doi: 10.3390/cancers17142309.
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. A < 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 ( = 0.002) and weight/BMI ( = 0.000) and all symptoms, except for appetite loss ( = 0.115) and pain ( = 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、生活质量及化疗治疗依从性。化疗引起的恶病质也与死亡率降低有关。本研究旨在评估恶病质相关指标和症状作为肺癌化疗试验方案结局的出现频率,并研究关键试验特征如何对其产生影响。 方法:我们对2012年至2023年在四个公共试验注册库中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,如身体活动、体重/体重指数(BMI)、饮食限制、热量摄入和瘦肌肉量。还提取了与症状相关的结局,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,记录了体能状态的数量和类型以及评估工具。数据进行描述性总结。采用卡方检验来检验试验结局与特征之间的关联,这些特征包括癌症类型、试验地点、首席研究员/资金来源、评估工具和试验开始年份。P < 0.05被认为具有统计学意义。 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%),大多数来自欧洲(50.4%)。试验首席研究员来自行业(5
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