Improving recovery in older colorectal cancer patients with sarcopenia
Intervention, Non-randomized Controlled, Non-masked and Comparative Study of Presurgical Conditioning in Colorectal Cancer Patients Who Present With Sarcopenia
This study is testing if exercise and nutrition can help older colon cancer patients with muscle loss recover better and have fewer infections after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Trial ID | NCT05491434 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of physical exercise and nutritional supplementation on the functional status of sarcopenic patients diagnosed with colon adenocarcinoma. By comparing the incidence of postoperative infections between patients with and without sarcopenia, the study seeks to determine if preoperative interventions can reduce complications. The assessment of sarcopenia will be conducted using CT imaging of the L3 vertebra, and the primary outcome will focus on the rate of infections within 30 days post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 years and older diagnosed with colon adenocarcinoma without synchronous metastases.
Not a fit: Patients with rectal cancer or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications in older colorectal cancer patients with sarcopenia.
How similar studies have performed: While the concept of addressing sarcopenia in cancer patients is gaining traction, this specific intervention approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 70 years old, * Colon adenocarcinoma without synchronous metàstasis, * No urgent surgery, * ECOG performance status ≤ 2, * no pregnancy or lactation, * signature of the informed consent, * ability to comply with the study indications. Exclusion Criteria: * rectal càncer, * Concomitant neoplastic disease in the last 5 years * medical or mental condition of the patient that compromises the authorization of informed consent, * Concomitant uncontrolled or stable medical condition, * Clinically significant heart disease (congestive heart failure, symptomatic coronary disease) * Refusal to participate in the study.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Ricardo Frago, Ph D
- Email: rfrago@bellvitgehospital.cat
- Phone: +34932607485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.