An interventional study of PRECAREX intervention and Usual Care in Colorectal Cancer Postoperative Complications, sponsored by Universidad de Granada. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment
PRECAREX is a pilot randomized clinical trial with a two-arm parallel design aimed at evaluating the feasibility and safety of a preoperative weight loss intervention combining supervised exercise and calorie restriction in patients undergoing colorectal cancer surgery. The trial will also explore whether this intervention may improve surgical outcomes compared with usual care.
Colorectal cancer is one of the most prevalent malignancies worldwide, positioned as the fifth most common type of cancer. Surgery remains the primary treatment for most patients, yet it triggers an important stress response often followed by postoperative complications. More than 40% of patients with colorectal cancer undergoing surgery experience such complications, an issue that importantly affect long-term prognosis and quality of life. In this context, patients with obesity are at a higher risk compared to their normal-weight counterparts. Thus, combating obesity in the preoperative period could be of great importance for enhancing post-surgical outcomes.
Prehabilitation - defined as the process of physiologically and metabolically preparing patients for surgery - has gained relevance during the last decade. It has been reported that prehabilitation can reduce postoperative complications in colorectal cancer patients undergoing surgery. However, the presence of obesity may diminish these benefits. In a previous work, we demonstrated that a multidisciplinary prehabilitation positively modulates pro-tumoral gene signatures in both tumor and non-tumor colonic tissues. Nevertheless, these effects were significantly attenuated in patients with obesity, suggesting a reduced benefit in this population. This highlights the clinical and social relevance of exploring whether a preoperative weight-loss intervention could further enhance surgical outcomes in this high-risk group.
Evidence from bariatric surgery suggests that preoperative weight loss significantly improves prognosis in individuals with obesity. Similar strategies may also benefit patients with colorectal cancer undergoing surgery, but current evidence is limited and derived from studies with low sample sizes and poor methodological quality. Caloric restriction is a well-known method that can effectively induce short-term weight loss. However, it is not exempt from certain adverse events as often results in 20-30% loss of lean muscle mass. Considering that >60% of patients with colorectal cancer are affected by malnutrition, and that this nutritional status is strongly associated with increased postoperative morbidity, combining caloric restriction with nutritional education appears to be essential. Exercise is a well-established approach that can prevent lean mass loss and improve post- surgical prognosis, thus being considered a key component of preoperative care.
To maximize the effectiveness and safety of these interventions, they should be delivered by interdisciplinary teams including surgeons, nutritionist and exercise physiologist. This is critical not only to reduce excess body weight, but also preserve muscle mass, optimize metabolic health and improve surgical resilience.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 20 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual care group will follow the usual institutional preoperative care
Other: Usual Care
Preoperative calorie restriction and supervised exercise
Other: PRECAREX intervention
Participants allocated to PRECAREX will complete a structured preoperative weight loss intervention combining individualized controlled caloric restriction and supervised combined exercise training. The intervention will last approximately 4 weeks, depending on the interval between inclusion and surgery. Its objective is to induce a controlled preoperative weight loss of approximately 5%, while preserving skeletal muscle function and improving functional reserve, with the primary clinical aim of reducing postoperative morbidity. The program is conceived as a supervised metabolic intervention targeting the biological profile of patients with obesity, characterized by excess adiposity, metabolic dysfunction, systemic inflammation, and reduced physiological adaptability.
Participants allocated to usual care will follow the 2025 standard ERAS-based perioperative pathway, including routine preoperative assessment, perioperative management, and postoperative follow-up. This may include standard nutritional screening and nutritional optimization according to hospital protocols and ERAS recommendations, including oral nutritional supplementation or immunonutrition when clinically indicated as part of routine care and independently of study allocation. No structured weight loss program, supervised exercise, or research-prescribed individualized hypocaloric dietary intervention will be provided. Physical activity and dietary intake will be monitored to account for potential behavioral changes and to document any usual-care nutritional or lifestyle advice received outside the intervention.
Feasibility of the preoperative intervention
Feasibility will be assessed through recruitment and retention rates, attendance at supervised exercise sessions, and adherence to the prescribed calorie restriction.
Time frame: From enrollment to surgery.
Safety of the preoperative intervention
Safety will be assessed by recording adverse events occurring during the intervention, including their severity.
Time frame: From intervention initiation to surgery.
Comprehensive Complication Index
Overall postoperative complication burden assessed using the Comprehensive Complication Index, which integrates all postoperative complications into a score ranging from 0 (no complications) to 100 (death).
Time frame: Within 30 and 90 days after surgery.
Incidence of postoperative complications
Proportion of participants experiencing at least one postoperative complication, expressed as a percentage.
Time frame: Within 30 and 90 days after surgery.
Incidence of major postoperative complications
Proportion of participants experiencing major postoperative complication (CCI \> 20), expressed as a percentage.
Time frame: Within 30 and 90 days after surgery.
Incidence of postoperative medical complications
Proportion of participants experiencing at least one medical complication, expressed as a percentage.
Time frame: Within 30 and 90 days after surgery.
Incidence of postoperative surgical complications
Proportion of participants experiencing at least one surgical complication, expressed as a percentage.
Time frame: Within 30 and 90 days after surgery.
Hospital length of stay
Number of days from surgery to discharge from the hospital.
Time frame: Within 90 days after surgery.
Emergency department visits
Proportion of participants attending emergency department after discharge, expressed as a percentage.
Time frame: Within 30 and 90 days after surgery.
Glycemic profile
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the glycemic profile. We will obtain plasma glucose (mg/dL) and insulin (mg/dL) levels.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Lipid profile
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the lipid profile. We will obtain total cholesterol (mg/dL), Light-Density Lipoprotein Cholesterol (mg/dL), High-Density Lipoprotein Cholesterol (mg/dL), and Triglycerides (mg/dL) levels.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Hepatic transaminases
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the hepatic transaminases levels. Serum alanine aminotransferase (ALT), aspartate aminotransferase (GOT), gamma-glutamyl transferase (GGT), and alkaline phosphatase (ALP) will be measured and expressed in units per litre (U/L).
Time frame: Baseline, preoperatively, and 1 month after surgery.
Immunological blood profiles
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the immunological blood profiles. The following parameters will be obtained: Leukocytes (10\*3 uL), Neutrophils (10\*3 uL), Lymphocytes (10\*3 uL), Monocytes (10\*3 uL), Eosinophils (10\*3 uL), Basophils (10\*3 uL) and LUC cells (10\*3 uL).
Time frame: Baseline, preoperatively, and 1 month after surgery.
Red cells
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the red cells levels, including red blood cell count (×10\^12/L), haemoglobin (g/dL), haematocrit (%), mean corpuscular volume (fL), mean corpuscular haemoglobin (pg), mean corpuscular haemoglobin concentration (g/dL), and red cell distribution width (%).
Time frame: Baseline, preoperatively, and 1 month after surgery.
Tumour markers
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the tumour markers levels (CA 19-9, CEA, CA 125, TPA and CA 15.3; all will be expressed as pg/mL))
Time frame: Baseline, preoperatively, and 1 month after surgery.
Systolic blood pressure
Changes in systolic blood pressure will be assessed by blood pressure monitor.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Diastolic lood pressure
Changes in diastolic blood pressure will be assessed by blood pressure monitor.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Cardiorespiratory fitness
Changes in cardiorespiratory fitness assessed using the six-minute walk test.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Upper body muscular strength
Changes in upper body muscular strength assessed through handgrip test.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Lower body muscular strength and power
Changes in lower body muscular strength will be assessed using the 30 seconds sit-to-stand test.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Lower body muscular strength and power
Changes in lower body muscular strength will be assessed using the 5 sit-to-stand test
Time frame: Baseline, preoperatively, and 1 month after surgery.
Body weight
Body weight (kilograms) will be measured by a digital scale
Time frame: Baseline, preoperatively, and 1 month after surgery.
Body height
Body height (meters and centimeters) will be measured by a stadiometer
Time frame: Baseline, preoperatively, and 1 month after surgery.
Fat Mass
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Time frame: Baseline, preoperatively, and 1 month after surgery.
Fat-free Mass
Fat-free Mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Time frame: Baseline, preoperatively, and 1 month after surgery.
Neck circumference
Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Time frame: Baseline, preoperatively, and 1 month after surgery.
Waist circumference
Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Time frame: Baseline, preoperatively, and 1 month after surgery.
Hip circumference
Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Time frame: Baseline, preoperatively, and 1 month after surgery.
Health-related quality of life
Changes in health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This 30-item questionnaire comprises five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single-item measures (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). All scale and single-item scores are transformed to a range of 0-100. Higher functional and global health status/quality of life scores indicate better functioning and quality of life, whereas higher symptom and financial difficulties scores indicate greater problems.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Fatigue
Changes in fatigue assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cancer Related Fatigue Module (EORT-QLQ-FA12). This is a 12-item validated multi-dimensional questionnaire evaluating physical fatigue (5 items), emotional fatigue (3 items), cognitive fatigue (2 items), and interference/social impact (2 single items) over the past week. Items are scored on a 4-point Likert scale (1 = Not at all, 4 = Very much). Raw scores for each subscale are linearly transformed into a standardized 0 to 100 metric. Higher scores indicate a higher level of fatigue severity and greater functional impairment.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Quality of life
General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L). Values ranged from 0 to 100. Higher values mean better outcome.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Symptoms of anxiety and depression
Changes in anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale (HADS). Minimum value: 0 // Maximum value: 21. Higher scores mean a better outcome.
Time frame: Baseline, preoperatively, and 1 month after surgery.
Sleep quality
Changes in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). PSQI global score ranges from 0 to 21, with a score higher than 5 indicating poor sleep quality
Time frame: Baseline, preoperatively, and 1 month after surgery.
Dietary pattern
Changes in dietary pattern assessed using the Food Frequency Questionnaire (FFQ).
Time frame: Baseline, preoperatively, and 1 month after surgery.
Molecular Characterization of Colon Tumor Tissue
Colon tumor tissue samples will be collected during surgical resection and analyzed using molecular techniques (e.g., gene expression profiling) to assess markers associated with tumor progression.
Time frame: Day of surgery
Fecal microbiota
Shotgun metagenomic sequencing of DNA extracted from stool samples to determine microbial functional capacity through the analysis of metabolic pathways.
Time frame: Baseline, preoperatively, and 1 month after surgery.
No study locations are listed for this record.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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