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

Primary Purpose

Stomach Neoplasm, Gastrointestinal Neoplasms, Digestive System Neoplasm

Status

Unknown status

Phase

Phase 2

Locations

Cuba

Study Type

Interventional

Intervention

Ocoxin-Viusid®

About this trial

This is an interventional supportive care trial for Stomach Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institute of Oncology and Radiobiology (INOR)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ocoxin-Viusid®

Arm Description

Outcomes

Primary Outcome Measures

Quality of Life

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

Quality of Life

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

Quality of Life

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

Quality of Life

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

Secondary Outcome Measures

Nutritional Status

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

Chemotherapy Tolerance

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

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

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)

Full Information

NCT ID

NCT03549494

First Posted

May 25, 2018

Last Updated

October 20, 2021

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT03549494

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 25, 2018 (Actual)

Primary Completion Date

June 15, 2022 (Anticipated)

Study Completion Date

September 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catalysis SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ocoxin-Viusid®

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Ocoxin-Viusid®

Intervention Description

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 Measure Information:

Title

Quality of Life

Description

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

Time Frame

5 months

Title

Quality of Life

Description

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

Time Frame

5 months

Title

Quality of Life

Description

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

Time Frame

5 months

Title

Quality of Life

Description

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

Time Frame

5 months

Secondary Outcome Measure Information:

Title

Nutritional Status

Description

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

Time Frame

5 months

Title

Chemotherapy Tolerance

Description

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").

Time Frame

5 months

Title

Adverse Events-AE

Description

Time Frame

5 months

Title

Results of laboratory tests

Description

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pedro P. Guerra Chaviano, Msc

Phone

+53-72164124

pedrop@cencec.sld.cu

Facility Information:

Facility Name

National Institute of Oncology and Radiobiology (INOR)

City

Havana

State/Province

La Habana

ZIP/Postal Code

10400

Country

Cuba

Individual Site Status

Recruiting

Facility Contact: