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

NCT03549494 | Completed Phase 2 DMC

• 1 other identifier: OOS-CANCER-8
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Quality of Life

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

  5 months

• Quality of Life

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

  5 months

• Quality of Life

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

  5 months

• Quality of Life

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

  5 months

Secondary Outcomes (4)

• Nutritional Status

  5 months

• Chemotherapy Tolerance

  5 months

• Adverse Events-AE

  5 months

• Results of laboratory tests

  5 months

Study Arms (1)

Ocoxin-Viusid®

EXPERIMENTAL

Dietary Supplement: Ocoxin-Viusid®

Interventions

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

Ocoxin-Viusid®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

National Institute of Oncology and Radiobiology (INOR)

Havana, La Habana, 10400, Cuba

Location

Related Publications (11)

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• Lagergren P, Fayers P, Conroy T, Stein HJ, Sezer O, Hardwick R, Hammerlid E, Bottomley A, Van Cutsem E, Blazeby JM; European Organisation for Research Treatment of Cancer Gastrointestinal and Quality of Life Groups. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-OG25, to assess health-related quality of life in patients with cancer of the oesophagus, the oesophago-gastric junction and the stomach. Eur J Cancer. 2007 Sep;43(14):2066-73. doi: 10.1016/j.ejca.2007.07.005. Epub 2007 Aug 15.

  PMID: 17702567 BACKGROUND

• Gomez EV, Perez YM, Sanchez HV, Forment GR, Soler EA, Bertot LC, Garcia AY, del Rosario Abreu Vazquez M, Fabian LG. Antioxidant and immunomodulatory effects of Viusid in patients with chronic hepatitis C. World J Gastroenterol. 2010 Jun 7;16(21):2638-47. doi: 10.3748/wjg.v16.i21.2638.

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MeSH Terms

Conditions

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Esophageal Neoplasms; Head and Neck Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Diseases; Stomach Diseases

Interventions

Ocoxin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: October 25, 2018
• Primary Completion: June 15, 2022
• Study Completion: February 15, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU (1)