Back to resultsEvaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma
Primary Purpose
Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Ocoxin-Viusid
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Neoplasm focused on measuring Nutritional supplement, Metastatic colorectal Cancer, Oxidative Stress, Ocoxin Viusid, Antioxidant
Eligibility 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.
Sites / Locations
- National Institute of Oncology and Radiobiology (INOR)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ocoxin-Viusid®
Arm Description
Outcomes
Primary Outcome Measures
Quality of life
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)
Quality of life
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).
Tolerance of Chemotherapy
Treatment with chemotherapy (CT) FOLFOX-IV will be considered
Nutritional status
Variations in the patient's nutritional status and weight at the end of treatment will be considered
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03559543
Brief Title
Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma
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
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 30, 2022 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasm, Rectal Diseases, Colonic Diseases, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease
Keywords
Nutritional supplement, Metastatic colorectal Cancer, Oxidative Stress, Ocoxin Viusid, Antioxidant
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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ocoxin-Viusid®
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Ocoxin-Viusid
Intervention Description
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 Measure Information:
Title
Quality of life
Description
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)
Time Frame
8 months
Title
Quality of life
Description
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).
Time Frame
8 months
Title
Tolerance of Chemotherapy
Description
Treatment with chemotherapy (CT) FOLFOX-IV will be considered
Time Frame
8 months
Title
Nutritional status
Description
Variations in the patient's nutritional status and weight at the end of treatment will be considered
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Oncology and Radiobiology (INOR)
City
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Learn more about this trial
Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma
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