Not yet recruitingNCT07928076ClinicalTrials.gov record

Preoperative Calorie Restriction and Exercise in Patients With Obesity Undergoing Colorectal Cancer Resection

Colorectal Cancer Postoperative Complications

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 20 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Body mass index greater than 30 kg/m² and less than 40 kg/m².
Diagnosis of nonmetastatic colorectal cancer that does not require surgery within less than two weeks of the baseline visit.
Not currently participating in any structured dietary intervention.\<
Physically inactive, defined as engaging in less than 600 MET-minutes per week of moderate-to-vigorous physical activity.
Ability to provide written informed consent.

Exclusion Criteria:

Medical contraindications to the prescribed intervention involving supervised exercise and calorie restriction.
Comorbidities requiring a specific dietary regimen incompatible with the proposed intervention.
Unintentional weight loss greater than 10% of body weight in the six months preceding the baseline visit, or greater than 5% in the three months preceding the baseline visit.
Planned neoadjuvant chemotherapy.
Clinical conditions that would preclude adequate testing of the study hypothesis.
Additional surgery planned within three months after colorectal cancer resection.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Single masked

Usual care

Usual care group will follow the usual institutional preoperative care

Other: Usual Care

PRECAREX intervention

Preoperative calorie restriction and supervised exercise

Other: PRECAREX intervention

PRECAREX intervention OTHER

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.

Usual Care OTHER

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Feasibility of the preoperative intervention

Time frame: From enrollment to surgery.

Feasibility will be assessed through recruitment and retention rates, attendance at supervised exercise sessions, and adherence to the prescribed calorie restriction.

Safety of the preoperative intervention

Time frame: From intervention initiation to surgery.

Safety will be assessed by recording adverse events occurring during the intervention, including their severity.

Secondary measures

Comprehensive Complication Index

Time frame: Within 30 and 90 days after surgery.

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).

Incidence of postoperative complications

Time frame: Within 30 and 90 days after surgery.

Proportion of participants experiencing at least one postoperative complication, expressed as a percentage.

Incidence of major postoperative complications

Time frame: Within 30 and 90 days after surgery.

Proportion of participants experiencing major postoperative complication (CCI \> 20), expressed as a percentage.

Incidence of postoperative medical complications

Time frame: Within 30 and 90 days after surgery.

Proportion of participants experiencing at least one medical complication, expressed as a percentage.

Incidence of postoperative surgical complications

Time frame: Within 30 and 90 days after surgery.

Proportion of participants experiencing at least one surgical complication, expressed as a percentage.

Hospital length of stay

Time frame: Within 90 days after surgery.

Number of days from surgery to discharge from the hospital.

Emergency department visits

Time frame: Within 30 and 90 days after surgery.

Proportion of participants attending emergency department after discharge, expressed as a percentage.

Glycemic profile