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NCT Number: NCT03549494

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

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.

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Key information

Conditions

Stomach Neoplasm Digestive System Disease Digestive System Diseases Digestive System Neoplasm Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophagogastric Junction Disorder Gastrointestinal Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Oncology and Radiobiology (INOR)

Havana, La Habana, 10400, Cuba

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients of any sex with age ≥ 18 years.
  • Patients with clinical status according to Karnofsky index ≥ 70%.
  • Patients with life expectancy ≥ 3 months.
  • Clinically fit patients to receive the FOLFOX chemotherapy scheme.
  • Patients who have signed informed consent for the investigation.
  • 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.
  • 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

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

Treatment and study plan

Ocoxin-Viusid®

Dietary Supplement

Ocoxin-Viusid group (Experimental). Oral solution of Ocoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), administrado preferably administered after breakfast and dinner. The product will dilute in water, milk or juice. The treatment will have a period of 19 weeks, starting 2 weeks before the onco-specific treatment with FOLFOX chemotherapy and will end 3 weeks after the end of the sixth cycle of chemotherapy. QT FOLFOX will be prescribed intravenously every 14 days for 6 cycles as follows: Oxaliplatin (85 mg x m2) on day 1 Folinic acid (200 mg x m2) on day 1 and 2 5 Fluoracil (400 mg x m2, bolus) on day 1 and 2 5 Fluoracil (600 mg x m2, continuous infusion) on day 1 and 2

Primary outcomes

  1. Quality of Life

    Time frame: 5 months

    Karnofsky index (Score of 0-100 points at intervals of 10).

  2. Quality of Life

    Time frame: 5 months

    EORTC QLQ-C30 (score of every item and global score)

  3. Quality of Life

    Time frame: 5 months

    EORTC QLQ-STO22 if gastric cancer (score of every item and global score)

  4. Quality of Life

    Time frame: 5 months

    EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score)

Secondary outcomes

  1. Nutritional Status

    Time frame: 5 months

    Body mass Index calculated by Weight/(Height*Height), the weight expressed in Kg and, the height expressed in meters.

  2. Chemotherapy Tolerance

    Time frame: 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").

  3. Adverse Events-AE

    Time frame: 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)

  4. Results of laboratory tests

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jun 8, 2018
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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