Clinical trial · Interventional
Immunosurveillance for Metastatic Colorectal Cancer
The Role of Neutrophil Mitochondrial Dysfunction in Medical Rehabilitation During Palliative Chemotherapy for Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if adding sodium nucleinate to FOLFOX chemotherapy helps people with metastatic colorectal cancer (colon or rectal cancer that has spread). Researchers will also look at side effects and how people feel during treatment. The main questions this study aims to answer are: 1. Does adding sodium nucleinate help treatment work better? 2. Does it improve quality of life (how people feel and function day to day)? 3. Does it affect survival at one year? Researchers will compare: 1. FOLFOX chemotherapy plus sodium nucleinate versus 2. FOLFOX chemotherapy alone Participants will: 1. Be randomly assigned (like flipping a coin) to one of the two groups; 2. Receive four cycles of FOLFOX chemotherapy; 3. Take sodium nucleinate daily if assigned to that group; 4. Have checkups and blood tests during the study (including tumor marker blood tests such as CEA and CA 19-9); 5. Complete quality-of-life questionnaires and have other planned tests that look at immune cells and how certain blood cells work; 6. Be followed after treatment to see how they are doing, including up to one year after starting the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Monitoring, Immunologic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adenorine | Dietary Supplement | — | UNRESOLVED |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy according to the FOLFOX regimen in combination with sodium nucleinate
- description
- Patients with metastatic colorectal cancer (stages T3-4 N1-2 M1) received four courses of FOLFOX chemotherapy combined with sodium nucleinate 50 mg/day (25 mg morning, 25 mg lunch) starting 1 week before the first cycle and continued daily for four months.
- interventionNames
- Dietary Supplement: Adenorine
- Drug: FOLFOX regimen
- type
- PLACEBO_COMPARATOR
- label
- Chemotherapy according to the FOLFOX regimen
- description
- Patients with metastatic colorectal cancer (stages T3-4 N1-2 M1) received four courses of FOLFOX chemotherapy alone. General and biochemical blood analyses were conducted monthly.
- interventionNames
- Other: Placebo
- Drug: FOLFOX regimen
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed colorectal cancer. 2. Locally advanced or metastatic disease as treated with palliative FOLFOX per protocol (including metastatic disease \[M1\]). 3. Able to receive FOLFOX chemotherapy and to comply with study procedures. 4. Provided written informed consent. Exclusion Criteria: 1. Active pulmonary tuberculosis. 2. Decompensated diabetes mellitus. 3. Decompensated cardiac, vascular, pulmonary, hepatic, or renal failure.
References
Publications (0)
Data not yet available