Evaluation of the effects of Supplementation with L-Citrulline in patients with stomach and colorectal Cancer undergoing Chemotherapy

Interventions: Experimental and control group: This is an evaluative, randomized, three-arm, double-blind, placebo-controlled study. All patients are volunteers at the Hospital Regional do Câncer de Passos, located in the city of Passos MG, selected according to the type of gastrointestinal cancer they have and the duration of the chemotherapy cycle. A total of fifteen people of both sexes met the inclusion criteria for the study. Before supplementation, all patients will undergo an assessment of nutritional status, where weight and height will be evaluated, as well as additional information regarding weight loss, usual weight, muscle mass, muscle weakness and sarcopenia. Prior to data collection and filling out the questionnaires, a detailed anamnesis will be carried out (Appendix I) containing information about identification, profession, age, family history of cancer, main GIT symptoms, lifestyle habits, physical examination, and food intake and symptoms of gastrointestinal cancers. The evaluation of the dietary pattern will be carried out using a food frequency questionnaire validated for colorectal cancer, the lifestyle will be evaluated with information from the medical records. For supplementation, the patients were divided into 3 groups according to the letter drawn (S, O, F), since all the pills came out of manipulation in unidentified packages, that is, the pills were manipulated and left the laboratory containing on their labels only the letters S, O and F, both the researchers who will evaluate the
outcomes such as participants will not know which group each participant belongs to. The patients were submitted to a raffle, where they themselves raffled one of the three letters. Therefore, the administration of L-Citrulline was carried out in patients submitted exclusivel;D12.125.095.226
Primary outcome(s): Evaluate the potential of L-citrulline for mitigating the side effects of toxicity caused by chemotherapy treatment, after supplementation for 28 days, based on the comparison of biochemical tests performed at the beginning and end of supplementation. We also want to find differences between the intervention groups and the placebo control group.

干预措施：试验组与对照组：本研究为一项评估性、随机三臂、双盲安慰剂对照临床试验。所有受试者均为来自巴西米纳斯吉拉斯州帕苏市帕苏地区癌症医院的志愿者，筛选依据为患者所患胃肠道癌症类型及化疗周期时长。最终共计15名男女患者符合本研究纳入标准。在开始补充干预前，所有患者将接受营养状况评估，内容包括体重与身高检测，同时收集体重下降情况、基线体重、肌肉量、肌肉无力及肌肉减少症相关信息。在开展数据收集与问卷填写前，还将进行详细的病史采集（附录I），涵盖患者身份信息、职业、年龄、癌症家族史、主要胃肠道症状、生活方式习惯、体格检查结果、膳食摄入情况及胃肠道癌症相关症状。膳食模式评估采用经结直肠癌人群效度验证的食物频率问卷，生活方式相关信息则通过受试者的病历资料获取。本次补充干预采用抽签分组方式，将患者分为3组，分组标识为S、O、F。所有受试药物均采用匿名包装配制，即药物由实验室制备完成后，仅在标签上标注字母S、O、F，负责结局评估的研究人员与受试者均无法知晓每名患者所属组别，以保障双盲设计的实施。患者将自行抽取字母完成分组。其中，L-瓜氨酸（L-Citrulline）的给药仅针对符合编号D12.125.095.226纳入标准的患者开展。主要结局指标：本研究旨在通过对比补充干预起始与结束时的生化检测结果，评估为期28天的L-瓜氨酸补充干预对缓解化疗所致毒性不良反应的潜在效果，同时探究各干预组与安慰剂对照组之间的差异。