Clinical trial NCT03717298: Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
Official title: Evaluation of the Effect of Ocoxin-Viusid® Nutritional Supplement in the Life Quality in Patients Diagnosed With Advanced Pancreatic Adenocarcinoma. Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Pancreas
Pancreatic Cancer
Advanced Cancer
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Pancreatic Diseases
Keywords: Nutritional supplement
Advanced Pancreatic adenocarcinoma
Ocoxin-Viusid
Oxidative stress
Antioxidant
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.

Detailed description: To assess the effect of Ocoxin-Viusid® on the quality of life of patients with advanced pancreatic adenocarcinoma.

To evaluate the effect of Ocoxin-Viusid® on the quality of life of patients. To evaluate the influence of Ocoxin-Viusid® on tolerance to onco-specific therapy.

Identify the changes that occur in the nutritional status of patients receiving the supplement.

To evaluate the toxicity of Ocoxin-Viusid® in combination with chemotherapy in patients with advanced pancreatic adenocarcinoma.

Eligibility criteria: Inclusion Criteria:

* 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 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.

Exclusion Criteria:

* Pregnant or lactating patients.
* Patients with known hypersensitivity to any of the active ingredients of the chemotherapy used
* Patients who are receiving another product under investigation.
* 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 brain metastases.
* 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 30 patients in the study, taking into account 10% of losses.

Primary outcomes:
measure: Quality of Life: EORTC QLQ-C30
timeFrame: 12 months
Secondary outcomes:
measure: Nutritional Status of the patient during Chemotherapy
timeFrame: 12 months
measure: Adverse Events-AE during Chemotherapy Test
timeFrame: 12 months
measure: Hematology test
timeFrame: 12 months
measure: Blood Chemistry test
timeFrame: 12 months
measure: Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test
timeFrame: 12 months
Other outcomes:
Locations:
city: La Habana
country: Cuba
facility: "Hermanos Ameijeiras" Surgical Clinical Hospital
Study officials:
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