NCT03559543CompletedPhase 2
Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma
Evaluation of the Effect of the Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Metastatic Colorectal Adenocarcinoma. Phase II
Source: ClinicalTrials.gov · Last updated 7 Feb 2024
Brief summary (registry, in English)
The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 6 Jun 2018
- Start date
- 25 Oct 2018
- Primary completion date
- 30 Jun 2022
- Lead sponsor
- Catalysis SL
- Diseases
- Colorectal cancer
- NCT number
- NCT03559543
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 25 Oct 2018 to the primary completion date, 30 Jun 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are receiving another product under investigation.
Other illness
- Patients with known hypersensitivity to (5 Fluoracil, Folinic Acid or Oxaliplatin).
- Patients with decompensated intercurrent diseases, including: hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial.
- Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
- It is planned to include a total of 40 patients in the study, taking into account 10% of losses.
Other
- Pregnant or lactating patients.
- Patients with brain metastases.
Who the study is looking for
- Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
- Patients that meet the diagnostic criteria.
- Patients with general health according to Karnofsky ≥70%.
- Life expectancy greater than or equal to 3 months.
- Patients eligible to receive FOLFOX-IV chemotherapy.
- Patients who have signed the informed consent.
- Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy:
- Hemoglobin ≥ 90 g / l
- Total Leukocyte Count ≥ 3.0 x 109 / L
- Absolute Neutrophil Count ≥1.5 x 109 / L
- Platelet Count ≥100 x 109 / L
- Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution.
- TGO and TGP values ≤2.5 times the upper limit of the normal interval established in the institution.
- Creatinine values within the normal limits of the institution.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Oncology and Radiobiology (INOR) Coordinator of this site? Confirm its status | Havana | Cuba | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.