Oncoxin®-Viusid®- Quality of life of patients with metastatic colorectal adenocarcinoma-adults-Phase II

Phase 2

• Conditions: Metastatic colorectal adenocarcinoma; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Rectal Diseases; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

• Registration Number: RPCEC00000276
• Lead Sponsor: Catalysis S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
2. Patients that meet the diagnostic criteria.
3. Patients with general health according to Karnofsky =70%.
4. Life expectancy greater than or equal to 3 months.
5. Patients eligible to receive chemotherapy FOLFOX-IV scheme.
6. Patients who have signed the informed consent.
7. 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 , Platelet Count =100 x 109/L, Total bilirubin values = 1.5 times the upper limit of the normal range established in the institution, AST and ALP values =2.5 times the upper limit of the normal interval established in the institution, Creatinine values within the normal limits of the institution.

Exclusion Criteria

1. Patients who are receiving another onco-specific product in research.
2. Patients with known hypersensitivity to (5 Fluoracil, folinic acid or oxaliplatin).
3. 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, endangers their health and his life during the study or his participation in the trial.
4. Pregnant or lactating women.
5. Patients with mental disorders that could limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
6. Patients with cerebral metastases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life (Instruments: EORTC QLQ-C30 and colorectal cancer specific QLQ-CR29, The final score and that of each item of both scales will be collected). Measurement time: at baseline, 3 months and final evaluation (4 weeks after finished the last cycle of chemotherapy).