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Completed

NCT Number: NCT03559543

Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

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.

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Key information

Conditions

Colorectal Neoplasm Colonic Diseases Colorectal Neoplasms Digestive System Disease Digestive System Diseases Digestive System Neoplasm Digestive System Neoplasms Gastrointestinal Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Disease Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Oncology and Radiobiology (INOR)

Havana, 10400, Cuba

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ocoxin-Viusid

Dietary Supplement

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Evaluation of the Effect of the Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Metastatic Colorectal Adenocarcinoma. Phase II

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Jun 18, 2018
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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