Oral nutritional support for colon cancer surgery patients
A Prospective Multicenter Randomized Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer. Peri-Nutri
This study tests if giving nutritional supplements to colon cancer surgery patients before and after their operation can help them recover better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oulu Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oulu) |
| Trial ID | NCT03863236 on ClinicalTrials.gov |
What this trial studies
This multicenter, unblinded, randomized study investigates the effects of preoperative and postoperative oral nutritional supplements (ONS) on patients undergoing surgery for colon cancer. Patients will receive ONS for at least two weeks before and ten days after surgery to assess its impact on nutritional status, complications, hospital stay duration, quality of life, and survival rates. The study aims to determine if ONS can reduce surgery-related morbidity and improve overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary adenocarcinoma of the colon who are eligible for curative surgery.
Not a fit: Patients with recurrent colon cancer, metastatic disease, or significant comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and survival rates for colon cancer patients undergoing surgery.
How similar studies have performed: Other studies have shown promising results with nutritional support in surgical patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Primary colon adenocarcinoma * Curative operation is possible * Patient has a life expectancy of at least 12 months * Patient signs the informed consent and agrees to attend all study visits Exclusion Criteria: * Recurrent colon adenocarcinoma * Metastatic disease * Cancer that will require multiorgan resection * Pregnant or suspected pregnancy * Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 5). * Patients with concurrent or previous malignant tumors within 5 years before the study enrollment * Patient undergoing emergency procedures * Dialysis * Liver dysfunction, child pugh B or worse * NRS score \<2 or \>5 * BMI under 18.5 * Weight loss 15% or more past 6 months * Serum albumin less than 30 without liver or renal dysfunction * Chronic malnutrition: short bowel syndrome, previous gastrectomy, pancreatic dysfunction * Language barrier or other reasons why informed consent is not possible
Where this trial is running
Oulu
- Oulu University Hospital — Oulu, Finland (Recruiting)
Study contacts
- Study coordinator: Raila Aro
- Email: railaaro@student.oulu.fi
- Phone: +358505794375
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.