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Protein, vitamin C and N acetyle cystein on inflamamtory factors in colorectal cancer patients

Effects of high protein diet, vitamin C and N-acetylcysteine supplemetation on nutritional risk indexes, inflammatory factors and clinical consequences in colorectal cancer patients undergoing colectomy in the intensive care unit: A double-blind, randomized, placebo-controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251222068408N1
Enrollment
60
Registered
2026-05-09
Start date
2026-02-04
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal adenocarcinoma. Malignant neoplasm of colon

Interventions

Intervention 1: Intervention Group A (Vitamin C + placebo for NAC):Patients will receive 1.5 g/kg/day of protein administered orally, via a nasogastric (NG) tube, or via percutaneous endoscopic gastro

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with colorectal adenocarcinoma who have undergone colectomy Age greater than 30 years Stable hemodynamic status and blood pressure (not requiring norepinephrine and vasoconstrictor medications during transfer to the ICU). Postopetaive survival expectency of at least 10 days as assessed by the surgeon

Exclusion criteria

Exclusion criteria: Lack of willingness to cooperate Individuals with hepatic metatatic disease Preganant of breastfeeding women Individuals with immune systems deficiencies Individuals taking Immunouppressive medications Individuals with glucose 6 phosphate dehydrogenase deficiency Individuals with preoperative white blood cell count greater than 11,000 Individuals with a history of calcium oxalate kidney stones Individuals with post operative fluid-intake restrictions Individuals with a history of renal diseases and elevated serum creatine levels above 1.5 mg/dl

Design outcomes

Primary

MeasureTime frame
Interleukin-6 (IL-6). Timepoint: This outcome will be assessed at baseline, before the intervention, and seven days after the intervention. Method of measurement: ELISA method.

Secondary

MeasureTime frame
Prealbumin. Timepoint: This outcome will be assessed at baseline, before the intervention, and seven days after the intervention. Method of measurement: Immunoassay techniques.;Albumin. Timepoint: This outcome will be assessed at baseline, before the intervention, and seven days after the intervention. Method of measurement: Immunoassay techniques.;C-reactive protein (CRP). Timepoint: This outcome will be assessed at baseline, before the intervention, and seven days after the intervention. Method of measurement: Immunoassay techniques.;Tumor necrosis factor-alpha (TNF-a). Timepoint: This outcome will be assessed at baseline, before the intervention, and seven days after the intervention. Method of measurement: Immunoassay techniques.;Neutrophil-to-lymphocyte ratio. Timepoint: This outcome will be assessed at baseline, before the intervention, and seven days after the intervention. Method of measurement: Flow cytometry with blood samples collected in EDTA-coated tubes.;Platelet-to-lymphocyte ratio. Timepoint: This outcome will be assessed at baseline, before the intervention, and seven days after the intervention. Method of measurement: Flow cytometry with blood samples collected in EDTA-coated tubes.;Overall survival rates. Timepoint: This outcome will be assessed 28 days and 6 months after the intervention. Method of measurement: Counting the number of patient survival days.;Nutrition Risk in the Critically Ill (NUTRIC) score. Timepoint: This outcome will be assessed at baseline, before the intervention, and seven days after the intervention. Method of measurement: The Nutritional Risk in Critically Ill (NUTRIC) score form will be completed for patients based on interleukin-6 levels before and after surgery. The Sequential Organ Failure Assessment (SOFA) score will be calculated based on bilirubin level, creatinine level, platelet count, Glasgow Coma Scale (GCS) score, and mean arterial pressure (MAP).;Length of stay (LOS). Timepoint: This outcome will be assessed

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Mirmiran

Shahid Beheshti University of Medical Sciences

Parvin.mirmiran@gmail.com+98 21 2235 7483

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026