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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549494
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE June 8, 2018
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE October 25, 2018
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • Quality of Life [ Time Frame: 5 months ]
    Karnofsky index (Score of 0-100 points at intervals of 10).
  • Quality of Life [ Time Frame: 5 months ]
    EORTC QLQ-C30 (score of every item and global score)
  • Quality of Life [ Time Frame: 5 months ]
    EORTC QLQ-STO22 if gastric cancer (score of every item and global score)
  • Quality of Life [ Time Frame: 5 months ]
    EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score)
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Quality of Life [ Time Frame: 5 months ]
    Karnofsky index
  • Quality of Life [ Time Frame: 5 months ]
    EORTC QLQ-C30
  • Quality of Life [ Time Frame: 5 months ]
    QLQ-STO22
  • Quality of Life [ Time Frame: 5 months ]
    QLQ-OG25
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • 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.
  • 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").
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Nutritional Status [ Time Frame: 5 months ]
    Body mass Index
  • Chemotherapy Tolerance [ Time Frame: 5 months ]
    Adverse Reactions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction
Official Title  ICMJE Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Ocoxin-Viusid®
Intervention: Dietary Supplement: Ocoxin-Viusid®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2021
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pedro P. Guerra Chaviano, Msc +53-72164124 pedrop@cencec.sld.cu
Listed Location Countries  ICMJE Cuba
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03549494
Other Study ID Numbers  ICMJE OOS-CANCER-8
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Catalysis SL
Study Sponsor  ICMJE Catalysis SL
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Catalysis SL
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP