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

February 6, 2024 updated by: Catalysis SL

Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • La Habana
      • Havana, La Habana, Cuba, 10400
        • National Institute of Oncology and Radiobiology (INOR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ocoxin-Viusid®
Dietary supplement: Ocoxin-Viusid®
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 5 months
Karnofsky index (Score of 0-100 points at intervals of 10).
5 months
Quality of Life
Time Frame: 5 months
EORTC QLQ-C30 (score of every item and global score)
5 months
Quality of Life
Time Frame: 5 months
EORTC QLQ-STO22 if gastric cancer (score of every item and global score)
5 months
Quality of Life
Time Frame: 5 months
EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score)
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months
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").
5 months
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)
5 months
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)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2018

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

February 15, 2023

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OOS-CANCER-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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