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Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03559543
Recruitment Status : Not yet recruiting
First Posted : June 18, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Brief Summary:
The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasm Rectal Diseases Colonic Diseases Intestinal Disease Gastrointestinal Disease Digestive System Disease 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 influence of Ocoxin®-Viusid® on tolerance to onco-specific therapy.
  • Identify the changes that occur in the nutritional status of patients receiving the supplement.
  • To evaluate the toxicity of Ocoxin®-Viusid® in combination with chemotherapy in patients with metastatic colorectal adenocarcinoma.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effect of the Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Metastatic Colorectal Adenocarcinoma. Phase II
Estimated Study Start Date : October 25, 2018
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Arm Intervention/treatment
Experimental: Ocoxin-Viusid® Dietary Supplement: Ocoxin-Viusid

An oral solution of Oncoxin® (30 ml vials) will be used at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and lunch. It will be prescribed for a period of 2 weeks before starting the QT up to 3 weeks after finishing the treatment.

The treatment with Oncoxin®-Viusid® will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the oncospecific treatment.

The treatment will be administered continuously for approximately 29 weeks from the patient's inclusion in the study.





Primary Outcome Measures :
  1. Quality of life [ Time Frame: 8 months ]
    Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: EORTC QLQ-C30 (general quality of life in cancer patients: Physical, Role, Emotional, Cognitive, Social, Overall quality of life, Fatigue, Nausea and vomiting, Pain valorated from 1 to 4)

  2. Quality of life [ Time Frame: 8 months ]
    Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: QLQ-CR29 specific questionnaire of quality of life in colon cancer (Urinary frequency, Blood and mucus in stool, Stool frequency and Body image, Urinary incontinence, Dysuria, Abdominal pain, Buttock pain , Bloating, Dry mouth, Hair loss, Taste, Anxiety, Weight, Flatulence, Faecal incontinence, Sore skin, Embarrassment, Stoma care problems, Sexual interest, Impotence, Dyspareunia valorated from 1 to 4).

  3. Tolerance of Chemotherapy [ Time Frame: 8 months ]
    Treatment with chemotherapy (CT) FOLFOX-IV will be considered

  4. Nutritional status [ Time Frame: 8 months ]
    Variations in the patient's nutritional status and weight at the end of treatment will be considered



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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:

  • Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
  • Patients that meet the diagnostic criteria.
  • Patients with general health according to Karnofsky ≥70%.
  • Life expectancy greater than or equal to 3 months.
  • Patients eligible to receive FOLFOX-IV chemotherapy.
  • Patients who have signed the informed consent.
  • Patients who have laboratory values in parameters 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 values ≤ 1.5 times the upper limit of the normal range established in the institution.
  • TGO and TGP values ≤2.5 times the upper limit of the normal interval established in the institution.
  • Creatinine values within the normal limits of the institution.

Exclusion Criteria:

  • Pregnant or lactating patients.
  • Patients with known hypersensitivity to (5 Fluoracil, Folinic Acid or Oxaliplatin).
  • Patients who are receiving another product under investigation.
  • Patients with decompensated intercurrent diseases, including: hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial.
  • Patients with brain metastases.
  • Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.

It is planned to include a total of 40 patients in the study, taking into account 10% of losses.


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): NCT03559543


Contacts
Contact: Ivis Mendoza Hernández, Msc 7 204 8742 ivis@cencec.sld.cu
Contact: Yaima Muñoz Morejón, Dr. 7 204 8742 yaima@cencec.sld.cu

Locations
Cuba
National Institute of Oncology and Radiobiology (INOR) Not yet recruiting
Havana, Cuba, 10400
Contact: Luis E. Alsina Tul, Dr.       lealsina@infomed.sld.cu   
Principal Investigator: Mayte Lima Pérez, Dr.         
Sub-Investigator: Jorge L. Soriano García, Dr.         
Principal Investigator: Luis E. Alsina Tul, Dr.         
Sub-Investigator: Yanelis Mir Espinosa, Dr.         
Sub-Investigator: Danay Corrales Otero, Dr.         
Sub-Investigator: Karelia Silvera Candó, BSc         
Sub-Investigator: Kirenia Silva Rodríguez, BSc         
Sub-Investigator: Gladys E. García Lemus, NP         
Sub-Investigator: Zaida Lastres Sosa, BSc         
Sub-Investigator: Janet Lamadrid García, Dr.         
Sub-Investigator: Martha I. Lugiollo Lugo, NP         
Sub-Investigator: Juan J. Lence Anta, Dr.         
Sub-Investigator: Ana M. Arias Prieto, BSc         
Sub-Investigator: María E. Suardiaz Espinosa, BSc         
Sub-Investigator: Martha González Dueñas, NP         
Sub-Investigator: Luis A. Fuentes Crespo, NP         
Sub-Investigator: Ana J. Artiles Morales, NP         
Sub-Investigator: Yolanda Cruz, NP         
Sub-Investigator: Jorge Ortiz Roque, Dr.         
Sub-Investigator: Ivelisse Fleites León, BSc         
Sub-Investigator: Dayanis Duvergel Calderín, Dr.         
Sub-Investigator: Carlos A. Domínguez Álvarez, Dr.         
Sub-Investigator: Robin García Diéguez, MSc         
Sponsors and Collaborators
Catalysis SL

Publications:

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03559543     History of Changes
Other Study ID Numbers: OOS-CANCER-9
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: June 2018
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)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catalysis SL:
Nutritional supplement
Metastatic colorectal Cancer
Oxidative Stress
Ocoxin Viusid
Antioxidant

Additional relevant MeSH terms:
Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Diseases
Intestinal Diseases
Intestinal Neoplasms
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site