Nutritional and activity program to support recovery after colon cancer surgery
Nutritional, Inflammatory, and Muscular Assessment (NIMA) in Patients With Colon Cancer
This study will test whether combining an HMB- and vitamin D–enriched nutritional supplement with a structured postoperative physical activity program helps adults with stage I–III colon cancer regain muscle strength and function after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Málaga, Malaga) |
| Trial ID | NCT07534852 on ClinicalTrials.gov |
What this trial studies
Colon cancer patients often lose muscle and nutritional status before and after surgery, which can slow recovery and reduce quality of life. This perioperative study provides routine preoperative nutritional care and then compares postoperative strategies that pair HMB- and vitamin D–enriched hypercaloric/hyperproteic supplementation with a supervised exercise program against standard nutrition and general activity advice. Participants are adults aged 18–75 with stage I–III colon cancer treated at Hospital Universitario Virgen de la Victoria in Málaga, Spain, and are followed through short- and medium-term recovery. Outcomes include muscle strength, physical function, nutritional markers, inflammatory and metabolic biomarkers, and gut microbiota changes.
Who should consider this trial
Good fit: Adults 18–75 years old with localized (stage I–III) colon cancer who are scheduled for primary surgical treatment and who can safely perform moderate-to-vigorous physical activity and take oral supplements are ideal candidates.
Not a fit: Patients with metastatic (stage IV) disease, rectal cancer, prior neoadjuvant therapy, severe comorbidities, contraindications to exercise or the supplements, pregnancy, or severe eating disorders are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the intervention could shorten functional recovery time, preserve or increase muscle strength, and improve nutritional and inflammatory profiles after colon cancer surgery.
How similar studies have performed: Previous studies of protein/HMB supplementation and perioperative or cancer rehabilitation exercise have shown benefit for preserving muscle and improving function, but combined perioperative HMB-plus-exercise programs in colon cancer are less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Málaga, Malaga
- Hospital Universitario Virgen de la Victoria — Málaga, Malaga, Spain (Recruiting)
Study contacts
- Principal investigator: Manuel Macías-Gonzalez, PhD — Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
- Study coordinator: Manuel Macías-González, PhD.
- Email: mmacias.manuel@gmail.com
- Phone: +34 952 36 76 00
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.