BackgroundCachexia is prevalent in gastrointestinal cancers and worsens patient outcomes and chemotherapy compliance. We examined to what extent registered gastrointestinal cancer chemotherapy clinical trials record measures and related symptoms of cachexia as outcomes, and whether these were associated with trial characteristics.MethodsFour public trial registries (2012–2022) were accessed for Phase II and/or III randomized controlled pancreatic, gastric, and colorectal cancer chemotherapy trial protocols. Trial outcome measures of overall survival and toxicity/side effects, and those related to cachexia [physical activity, weight/body mass index (BMI), dietary limitations, caloric intake, lean muscle mass] and symptoms (appetite loss, diarrhoea, pain, fatigue/insomnia, constipation, nausea, vomiting, and oral mucositis) were extracted, along with the number and types of performance status and patient‐reported outcomes (PROs) tools. Data were summarized descriptively. Chi‐square tests examined associations between outcomes and trial characteristics (cancer type, trial location, funding source, PROs tools, and commencement year). Statistical significance was set at P < 0.05.ResultsWe included 540 trial protocols (pancreatic (35.2%), colorectal (33.3%) and gastric (31.5%)), with most trials from Europe (44.1%). Trial lead investigator was from academia (28.3%), industry (27.6%) and government (26.3%). Allied health professional involvement (26.9%) occurred at eligibility. Adjuvant therapy in trials was mainly treatment‐related (68.1%). Additional medication included anti‐nausea (2.2%) and analgesia (0.9%). Trial protocols mostly recorded overall survival (90.4%) and toxicity (78.9%), and the symptoms appetite loss (26.1%) and diarrhoea (19.1%), with the other symptoms recorded in <10% of the trials. Reporting of physical activity (P = 0.001), dietary limitations (P = 0.002), lean muscle mass (P = 0.027), appetite loss (P < 0.001), pain (P = 0.001), nausea (P = 0.012), and oral mucositis (P = 0.049) varied depending cancer type. Toxicity/side effects (P = 0.022), physical activity (P < 0.001), appetite loss, nausea, and vomiting (all P < 0.001), diarrhoea (P = 0.010), pain (P = 0.001), fatigue/insomnia (P = 0.001) varied depending on the trial location. Trial funding was predominantly from private/industry (34.3%) and influenced the reporting of overall survival (P = 0.049), weight/BMI (P = 0.005), caloric intake (P = 0.015), and pain (P = 0.031). Performance status and PROs tools were mentioned in 91.2% and 46.3% of the trials, respectively. Trials that incorporated PROs tools were more likely to report cachexia related outcomes, except for overall survival, lean muscle mass, and oral mucositis. The proportion of trials measuring weight/BMI increased with trial commencement year (P = 0.04).ConclusionsCachexia‐related outcomes were under‐recorded in gastrointestinal cancer chemotherapy trials. As trial patients experience a high symptom burden, cachexia‐relevant measures and symptoms should be assessed throughout the trial, and integrated with primary endpoints to support their progress.

中文翻译：

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恶病质的测量和相关症状是否记录为胃肠道癌症化疗临床试验的结果？

背景恶病质在胃肠道癌症中普遍存在，会恶化患者的预后和化疗依从性。我们检查了注册的胃肠癌化疗临床试验在多大程度上记录了恶病质的测量和相关症状作为结果，以及这些是否与试验特征相关。方法访问了四个公共试验注册中心（2012-2022）进行 II 期和/或 III 期随机对照研究胰腺癌、胃癌和结直肠癌化疗试验方案。总体生存率和毒性/副作用的试验结果测量，以及与恶病质[体力活动、体重/体重指数（BMI）、饮食限制、热量摄入、瘦肌肉质量]和症状（食欲不振、腹泻、疼痛、提取疲劳/失眠、便秘、恶心、呕吐和口腔粘膜炎），以及表现状态和患者报告结果（PRO）工具的数量和类型。数据进行了描述性总结。卡方检验检查了结果与试验特征（癌症类型、试验地点、资金来源、PRO 工具和开始年份）之间的关联。统计显着性设定为磷< 0.05。结果我们纳入了 540 个试验方案（胰腺（35.2%）、结直肠（33.3%）和胃（31.5%）），其中大多数试验来自欧洲（44.1%）。试验主要研究者来自学术界（28.3%）、工业界（27.6%）和政府（26.3%）。联合医疗专业人员的参与（26.9%）发生在符合资格的情况下。试验中的辅助治疗主要与治疗相关（68.1%）。其他药物包括抗恶心（2.2%）和镇痛（0.9%）。试验方案主要记录总生存期（90.4%）和毒性（78.9%），以及食欲不振（26.1%）和腹泻（19.1%）的症状，其他症状记录的试验数量<10%。身体活动报告（磷= 0.001），饮食限制（磷= 0.002), 瘦肌肉质量 (磷= 0.027), 食欲减退 (磷< 0.001), 疼痛 (磷= 0.001), 恶心 (磷= 0.012）和口腔粘膜炎（磷= 0.049）根据癌症类型而变化。毒性/副作用（磷= 0.022), 体力活动 (磷< 0.001)、食欲不振、恶心和呕吐（全部磷< 0.001), 腹泻 (磷= 0.010), 疼痛 (磷= 0.001), 疲劳/失眠 (磷= 0.001）根据试验地点而变化。试验资金主要来自私人/工业（34.3%），并影响总体生存率的报告（磷= 0.049), 体重/BMI (磷= 0.005), 热量摄入 (磷= 0.015) 和疼痛 (磷= 0.031）。 91.2% 和 46.3% 的试验分别提到了性能状态和 PRO 工具。纳入 PROs 工具的试验更有可能报告恶病质相关结果，但总体生存率、瘦肌肉质量和口腔粘膜炎除外。测量体重/体重指数的试验比例随着试验开始年份的增加而增加（磷= 0.04）。结论在胃肠道癌症化疗试验中，与恶病质相关的结果记录不足。由于试验患者经历较高的症状负担，因此应在整个试验过程中评估恶病质相关的措施和症状，并与主要终点相结合以支持其进展。