Pancreatic cancer
Conditions
Interventions
Oncoxin-Viusid group (Experimental). Oral solution of Oncoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatme
Dietary Supplements
Administration, Oral
Sponsors
Laboratories Catalysis, S.A
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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. 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, Absolute Neutrophil Count =1.5 x 109 / L. o 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 and, Creatinine values within the normal limits of the institution.
Exclusion criteria
Exclusion criteria: 1- Patients who are receiving another product under investigation. 2- Patients with known hypersensitivity to any of the active ingredients of the chemotherapy used 3- Patients with decompensated intercurrent diseases, including: HBP, 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. 4-Patients who are pregnant or breastfeeding. 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 brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life (General Quality of Life EORTC QLQ-C30). Measurement time: at baseline and, 3, 6, 9, 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Related to the efect: 1. Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) in time and the doses are planned (Data related to administration or not of the CT/IT in the planned time, number of the cycle administered out of date, Days elapsed since the previous cycle and, cause that caused the administration of the CT/IT outside the planned date. In the case of the dose, the medication in which it was modified will be taken into account, as well as the modified dose). Measurement time: During the time of the CT/IT concurrent, and then, during the time of it. 2. Nutritional status (Body Mass Index). Measurement time: At baseline and, 3, 6, 9 and, 12 months Related to the Safety 3. Adverse Events-AE (Occurrence of an AE in the subject [Yes, No]; Description of the AE [Name of the event]; Duration of the AE [Difference between the start and end date of the event]; Intensity of the AE [According to CTCAE version 4 it will classify in Light, Moderate, Severe, Life-threatening consequences, Death related to AE]; Seriousness of the AE [serious or not serious], Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or sequelae], Causal relationship [According to WHO algorithm it will classify in very probable, probable, possible, improbable, unrelated, not evaluable]). Measurement time: 3, 6, 9, 12 months. 4. Hematology tests (Hemoglobin, Platelets, Hemogram with differential). Measurement time: at baseline and, 3, 6, 9, 12 months. 5. Blood Chemistry tests (GPT, GOT, Creatinine, Glycemia, Bilirrubin, Alkaline Phosphatase, LDH). Measurement time: at baseline and, 3, 6, 9, 12 months. | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernandez
National Coordinator Center of Clinical Trials (CENCEC)
Outcome results
None listed