Clinical trial NCT03549494: Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction
Official title: Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasm
Gastrointestinal Neoplasms
Digestive System Neoplasm
Esophageal Neoplasms
Head and Neck Neoplasms
Gastrointestinal Disease
Digestive System Disease
Esophageal Diseases
Stomach Diseases
Esophagogastric Junction Disorder
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 45
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: Our main objective is to evaluate the effect of Ocoxin-Viusid on the quality of life of patients with advanced stomach cancer and esophagogastric junction. The Ocoxin-Viusid nutritional supplement is expected to improve quality of life and tolerance to treatment with Chemotherapy.

Detailed description: * To evaluate the effect of Ocoxin-Viusid on the quality of life of patients
* To evaluate the toxicity of Ocoxin-Viusid in combination with chemotherapy (QT).
* To assess the influence of Ocoxin-Viusid on tolerance to treatment with chemotherapy.
* Identify the changes that occur in the nutritional status of patients receiving the supplement.

Eligibility criteria: Inclusion Criteria:

1. Patients with cyto-histological diagnosis of stomach adenocarcinoma and gastric esophageal junction in stages III and IV, which are tributaries of the FOLFOX chemotherapy scheme.
2. Patients of any sex with age ≥ 18 years.
3. Patients with clinical status according to Karnofsky index ≥ 70%.
4. Patients with life expectancy ≥ 3 months.
5. Clinically fit patients to receive the FOLFOX chemotherapy scheme.
6. Patients who have signed informed consent for the investigation.
7. Patients with laboratory parameters within normal limits 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 ≤ 1.5 times the upper limit of the normal range established in the institution, TGO / TGP ≤2.5 times the upper limit of the normal range established in the institution, creatinine within the limits normal of the institution.
8. Patients of childbearing age with negative pregnancy test and use appropriate contraceptive methods such as intrauterine devices, barrier or tubal ligation methods, hormonal contraceptives. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.

Exclusion Criteria:

1. Patients with stomach cancer and gastric esophageal junction in stages III and IV, tributaries of surgical treatment and / or radiotherapy.
2. Patients who are being treated with another product under investigation.
3. Patients with known hypersensitivity to any component of the investigational product.
4. Patients with known hypersensitivity to any component of the Chemotherapy (FOLFOX).
5. Patients with acute allergic states or history of severe allergic reactions.
6. Patients with acute, chronic, or inflammatory decompensated infectious diseases.
7. Patients with brain metastases.
8. Patients with psychiatric disorders that make it difficult to collect information, treatment or follow-up.
9. Patients in the period of breast-feeding or puerperium.

Primary outcomes:
measure: Quality of Life
timeFrame: 5 months
measure: Quality of Life
timeFrame: 5 months
measure: Quality of Life
timeFrame: 5 months
measure: Quality of Life
timeFrame: 5 months
Secondary outcomes:
measure: Nutritional Status
timeFrame: 5 months
measure: Chemotherapy Tolerance
timeFrame: 5 months
measure: Adverse Events-AE
timeFrame: 5 months
measure: Results of laboratory tests
timeFrame: 5 months
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: National Institute of Oncology and Radiobiology (INOR)
state: La Habana
Study officials:
References:
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