Nutritional, Inflammatory, and Muscular Assessment (NIMA) in Patients With Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in phase angle (PhA)
研究概览
简要总结
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.
详细描述
Colon cancer patients frequently present with nutritional impairment, systemic inflammation, and early loss of muscle mass even before surgical treatment. These conditions may be exacerbated by surgical stress, reduced intake, and postoperative physical inactivity, leading to delayed recovery, functional decline, and impaired quality of life. Interventions targeting nutritional and functional status across the perioperative period may help improve physiological reserve and support postoperative recovery.
The NIMA study (Nutritional, Inflammatory, and Muscular Assessment) is designed to evaluate the impact of perioperative nutritional care and postoperative physical activity strategies on recovery, muscle strength, nutritional status, inflammation, metabolic health, and gut microbiota in adults undergoing surgery for colon cancer. The study combines routine preoperative nutritional management with a structured postoperative intervention and follow-up period, allowing assessment of short- and medium-term changes during recovery.
Study Setting and Population: This study includes adult patients diagnosed with colon cancer stages I to III, (TNM classification) who undergo surgical treatment at the Hospital Universitario Virgen de la Victoria in Málaga, Spain. Participants are identified and recruited before surgery through standard clinical pathways. All participants provide written informed consent before enrollment. The study is conducted in accordance with ethical principles and has been approved by the appropriate ethics committee.
Prehabilitation Phase (Preoperative Nutritional Care): Approximately two weeks before surgery, patients undergo a prehabilitation phase integrated into routine clinical care provided by the Endocrinology and Nutrition Department. This phase includes assessment and optimization of nutritional status through clinical evaluation, follow-up, and oral hypercaloric and hyperproteic supplementation when indicated. The aim is to improve metabolic condition and physiological reserve prior to surgical stress.
Surgical Treatment and Standard Postoperative Care: All participants undergo standard surgical treatment and postoperative oncological management according to institutional clinical practice. Participation in the study does not modify surgical procedures, immediate postoperative care, or oncological treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the interventions, participants and care providers are not blinded. Data analysis will be performed using coded group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Male and female participants.
- •Diagnosis of colon cancer at localized or locally advanced stages (TNM stages I-III).
- •Patients scheduled for primary surgical treatment.
排除标准
- •Metastatic disease (stage IV)
- •Diagnosis of rectal cancer or tumors involving the rectum
- •Prior neoadjuvant chemotherapy or radiotherapy before surgery.
- •Presence of synchronous malignant tumors.
- •Pregnant or breastfeeding women.
- •Presence of severe medical conditions, including acute pancreatitis, severe liver or kidney disease, heart failure, severe pulmonary disease, or peripheral arterial disease affecting the lower limbs.
- •Diagnosis of anorexia nervosa or other severe eating disorders.
- •Known allergy or intolerance to any nutritional supplements used in the study.
- •Medical contraindications to moderate-to-vigorous physical activity.
- •Regular participation in high-intensity exercise programs.
- •High risk of poor adherence to the study procedures, as determined by the study team.
研究组 & 干预措施
Standard nutritional care + supervised exercise program
Participants receive postoperative standard nutritional care according to routine clinical practice and individualized nutritional assessment. In addition, they participate in a structured supervised exercise program including progressive resistance and functional exercises targeting major muscle groups, adapted to their clinical condition.
干预措施: Standard hypercaloric-hyperproteic nutritional supplementation (Dietary Supplement)
Standard nutritional care + supervised exercise program
Participants receive postoperative standard nutritional care according to routine clinical practice and individualized nutritional assessment. In addition, they participate in a structured supervised exercise program including progressive resistance and functional exercises targeting major muscle groups, adapted to their clinical condition.
干预措施: Supervised exercise program (Behavioral)
Enhanced nutritional supplementation + non-structured physical activity
Participants receive postoperative enhanced nutritional supplementation, including beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, in addition to standard nutritional care based on routine clinical practice and individualized nutritional assessment. Participants also receive general physical activity recommendations according to standard postoperative care without participation in a structured exercise program.
干预措施: HMB-enriched hypercaloric-hyperproteic nutritional supplementation with vitamin D and calcium (Dietary Supplement)
Enhanced nutritional supplementation + non-structured physical activity
Participants receive postoperative enhanced nutritional supplementation, including beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, in addition to standard nutritional care based on routine clinical practice and individualized nutritional assessment. Participants also receive general physical activity recommendations according to standard postoperative care without participation in a structured exercise program.
干预措施: General physical activity recommendations (Behavioral)
Enhanced Nutritional Supplementation + Supervised Physical Activity
Participants receive postoperative enhanced nutritional supplementation, including beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, in addition to standard nutritional care based on routine clinical practice and individualized nutritional assessment. In addition, they participate in a structured supervised exercise program including progressive resistance and functional exercises targeting major muscle groups, adapted to their clinical condition.
干预措施: HMB-enriched hypercaloric-hyperproteic nutritional supplementation with vitamin D and calcium (Dietary Supplement)
Enhanced Nutritional Supplementation + Supervised Physical Activity
Participants receive postoperative enhanced nutritional supplementation, including beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, in addition to standard nutritional care based on routine clinical practice and individualized nutritional assessment. In addition, they participate in a structured supervised exercise program including progressive resistance and functional exercises targeting major muscle groups, adapted to their clinical condition.
干预措施: Supervised exercise program (Behavioral)
Standard nutritional care + general physical activity recommendations
Participants receive postoperative standard nutritional care according to routine clinical practice and individualized nutritional assessment. Participants also receive general physical activity recommendations according to standard postoperative care without participation in a structured exercise program.
干预措施: Standard hypercaloric-hyperproteic nutritional supplementation (Dietary Supplement)
Standard nutritional care + general physical activity recommendations
Participants receive postoperative standard nutritional care according to routine clinical practice and individualized nutritional assessment. Participants also receive general physical activity recommendations according to standard postoperative care without participation in a structured exercise program.
干预措施: General physical activity recommendations (Behavioral)
结局指标
主要结局
Change in phase angle (PhA)
时间窗: Baseline (first postoperative visit) and 6 months follow-up
Phase angle will be assessed by bioelectrical impedance analysis (BIA) as a bioelectrical marker of nutritional and cellular status. Results will be expressed in degrees.
Change in quadriceps rectus femoris cross-sectional area
时间窗: Baseline (first postoperative visit) and 6 months follow-up
Muscle mass will be assessed using nutritional ultrasound by measuring the cross-sectional area of the quadriceps rectus femoris at a standardized anatomical site (cm²).
次要结局
- Plasma concentration of inflammatory and metabolic biomarkers measured by multiplex immunoassay(From baseline (first postoperative visit), 3 months and 6 months follow-up)
- Percentage of DNA methylation in peripheral blood mononuclear cells (PBMCs)by quantitative PCR(Baseline (first postoperative visit) and 6 months follow-up)
- Change in urinary oxylipin concentrations by UHPLC-MS/MS(Baseline (first postoperative visit) and 6 months follow-up)
- Change in relative abundance of gut microbiota taxa(Baseline (first postoperative visit) and 6 months follow-up)
- Change in health-related quality of life score (EORTC QLQ-C30)(Baseline (first postoperative visit), 3 months, and 6 months follow-up)