Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction

Phase 2

Completed

• Conditions: Esophageal Neoplasms; Head and Neck Neoplasms; Digestive System Neoplasm; Gastrointestinal Disease; Stomach Diseases; Stomach Neoplasm; Gastrointestinal Neoplasms; Esophageal Diseases; Digestive System Disease; Esophagogastric Junction Disorder
• Interventions: Dietary Supplement: Ocoxin-Viusid®

• Registration Number: NCT03549494
• Lead Sponsor: Catalysis SL

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.

Study Timeline

• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Study Start: 2018-10-25
• Primary Completion: 2022-06-15
• Study Completion: 2023-02-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ocoxin-Viusid®	Ocoxin-Viusid®	-

Primary Outcome Measures

Name	Time	Method
Quality of Life	5 months	EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score)

Secondary Outcome Measures

Name	Time	Method
Adverse Events-AE	5 months	AE will be measured as: - Type of AE (Description of the EA that is presented) - Causal Agent (QT, Oncoxin -Viusid, Other) - Seriousness of the AE (Serious, Not serious) - Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death, according to the Common Criteria of Adverse Event Terminology (CTCAE) version 4.0) - Duration of the AE (Difference between the start and end date of the event) - Causal relationship (Very likely/Definitive, Probable, Possible, Unlikely, Not related, Not assessable/Not classifiable according to the WHO classification) - Attitude towards treatment (No change, Modification of doses, Temporary interruption, Definitive interruption)
Results of laboratory tests	5 months	Hematological (hemoglobin, platelets, total leukocytes, CAN) and Blood chemistry (AST, ALT, total bilirubin, creatinine, glycemia, albumin, total proteins, alkaline phosphatase) .The values will be recorded according to the units established for each test, reporting as normal, abnormal, not clinically significant, abnormal clinically significant and not performed, according to the normality ranges of the institution)
Nutritional Status	5 months	Body mass Index calculated by Weight/(Height\*Height), the weight expressed in Kg and, the height expressed in meters.
Chemotherapy Tolerance	5 months	Adverse Reactions (It will consider the compliance to the Chemotherapy treatment in terms of time and doses plan and, it will classify in "Yes, No").

Trial Locations

Locations (1)

National Institute of Oncology and Radiobiology (INOR); 🇨🇺 Havana, La Habana, Cuba