NIMA-Colon Cancer Study
报名条件(概要)
- 年龄:18 Years – 75 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
Spain
药品与企业信息
其他名称:Standard Nutrition
Participants receive a standard oral nutritional supplementation consisting of a hypercaloric and hyperproteic formula designed to support recovery and nutritional status in patients undergoing surgery.
其他名称:Enhanced Nutritional Supplementation
Participants receive an oral hypercaloric and hyperproteic nutritional supplementation enriched with β-hydroxy β-methylbutyrate (HMB) and supplemented with vitamin D and calcium. This formulation is designed to support muscle mass preservation and functional recovery in patients undergoing surgical treatment.
其他名称:Supervised Physical Activity
Participants follow a structured and supervised physical activity program including resistance exercises and functional training. Physical activity levels are periodically monitored using wearable activity devices.
其他名称:General Physical Activity
Participants receive general recommendations for physical activity according to routine clinical practice but do not participate in the structured supervised exercise program.
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
合作机构
- Instituto de Salud Carlos IIIOTHER_GOV
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
The goal of this study is to evaluate the effects of nutritional supplementation and physical activity interventions on recovery, muscle strength, nutritional status, inflammation, and metabolic health in adults with colon cancer undergoing surgery. Patients with colon cancer frequently experience loss of muscle mass, reduced physical function, and nutritional deterioration both before and after surgery, which may adversely affect recovery and quality of life. A key objective of this study is to assess whether a postoperative intervention combining nutritional supplementation with beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, together with a structured physical activity program, can improve muscle strength and functional recovery following colon cancer surgery. This study aims to answer the following questions: * Does nutritional supplementation with HMB and vitamin D, combined with postoperative physical activity, improve muscle strength and physical function following colon cancer surgery? * How do nutritional and lifestyle interventions influence nutritional status, gut microbiota composition, and biological markers of inflammation and metabolism during the recovery period? * Are there differences in recovery outcomes between patients receiving different types of nutritional support, with or without supervised physical activity? Participants will be adults diagnosed with colon cancer who undergo surgical treatment at the Hospital Universitario Virgen de la Victoria in Málaga, Spain. Patients will be recruited prior to surgery and will enter a prehabilitation phase integrated into routine care provided by the Endocrinology and Nutrition Department. During this prehabilitation phase, nutritional status will be assessed and optimized using standard clinical care, including oral nutritional supplementation when indicated. The aim is to improve the patient's condition before surgery. Approximately one month after surgery, once initial postoperative recovery has been completed, participants will enter the intervention and assessment phase (baseline visit). Participants will then be randomly assigned to one of four study groups in a 2×2 factorial design. These groups combine two nutritional strategies (standard care or supplementation with HMB and vitamin D) and two physical activity approaches (supervised exercise or general activity recommendations). The physical activity component, supervised by the Endocrinology and Nutrition team, will be objectively evaluated using an accelerometer-based device. Participants will be followed for approximately six months, with assessments at about 3 and 6 months after the baseline visit. At each visit, participants will undergo: * Body composition measurements * Muscle strength and physical performance tests * Collection of blood, urine, and stool samples * Questionnaires on health status and quality of life The results of this study will contribute to a more profound understanding of how tailored nutritional strategies and postoperative physical activity may support recovery and functional health in patients undergoing surgery for colon cancer.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Manuel Macías-González, PhD.mmacias.manuel@gmail.com+34 952 36 76 00
- Libia Alejandra Garcia-Flores, PhD.libia.garcia@ibima.eu+34 952 36 76 00
研究中心联系方式
- Hospital Universitario Virgen de la VictoriaMálaga,Malaga,Spain
问自己是否符合条件、如何预筛
我的病情档案
档案只保存在您自己的浏览器里,不会上传,任何人(包括本站)都看不到。
英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: NIMA-Colon Cancer Study ClinicalTrials.gov Identifier: NCT07534852 Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Investigational product: Standard hypercaloric-hyperproteic nutritional supplementation, HMB-enriched hypercaloric-hyperproteic nutritional supplementation with vitamin D and calcium, Supervised exercise program, General physical activity recommendations About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:NIMA-Colon Cancer Study 试验编号:NCT07534852 申办方:Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 研究药物:Standard hypercaloric-hyperproteic nutritional supplementation、HMB-enriched hypercaloric-hyperproteic nutritional supplementation with vitamin D and calcium、Supervised exercise program、General physical activity recommendations 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。