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

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ClinicalTrials.gov Identifier: NCT03549494
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Ocoxin-Viusid® Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549494


Contacts
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Contact: Pedro P. Guerra Chaviano, Msc +53-72164124 pedrop@cencec.sld.cu

Locations
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Cuba
National Institute of Oncology and Radiobiology (INOR) Recruiting
Havana, La Habana, Cuba, 10400
Contact: Luis E. Alsina Tul, Dr.    +53-78388589    lealsina@infomed.sld.cu   
Principal Investigator: Luis E. Alsina Tul, Dr.         
Sub-Investigator: Yanelys Mir Espinosa, Dr.         
Sub-Investigator: Giselle Álvarez Pérez, BSc         
Sub-Investigator: Karelia Silvera Candó, BSc         
Sub-Investigator: Zaida Lastre Sosa, BSc         
Sub-Investigator: Janet Lamadrid García, Dr.         
Sub-Investigator: Danay Corrales Otero, Dr.         
Sub-Investigator: Marta Lugioyo Lugo, BSc         
Sub-Investigator: Juan J. Lence Anta, Dr.         
Sponsors and Collaborators
Catalysis SL

Publications:

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Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03549494     History of Changes
Other Study ID Numbers: OOS-CANCER-8
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Diseases
Stomach Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site