Back to resultsEvaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
Primary Purpose
Adenocarcinoma of the Pancreas, Pancreatic Cancer, Advanced Cancer
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Ocoxin-Viusid®
Sponsored by
About this trial
This is an interventional supportive care trial for Adenocarcinoma of the Pancreas focused on measuring Nutritional supplement, Advanced Pancreatic adenocarcinoma, Ocoxin-Viusid, Oxidative stress, 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 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 any of the active ingredients of the chemotherapy used
- 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 30 patients in the study, taking into account 10% of losses.
Sites / Locations
- "Hermanos Ameijeiras" Surgical Clinical Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ocoxin-Viusid
Arm Description
It will be used at a rate of 60 ml daily (1 vial every 12 hours).
Outcomes
Primary Outcome Measures
Quality of Life: EORTC QLQ-C30
Life quality measurement through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (ORTC QLQ-C30): an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. It's composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Secondary Outcome Measures
Nutritional Status of the patient during Chemotherapy
Variations in the patient's nutritional status will be considered, measured by body mass Index (a measure of body fat based on height and weight that applies to adult men and women)
Adverse Events-AE during Chemotherapy Test
A test with the following questions:
Occurrence of an AE in the subject [Yes, No]; Description of the AE [Name of the event]; Duration of the AE [Difference between the start and end date of the event]; Intensity of the AE [According to CTCAE version 4 it will classify in Light, Moderate, Severe, Life-threatening consequences, Death related to AE]; Seriousness of the AE [serious or not serious], Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or sequelae], Causal relationship [According to WHO algorithm it will classify in very probable, probable, possible, improbable, unrelated, not evaluable]
Hematology test
Levels of Hemoglobin, Platelets, Hemogram with differential in blood extractions.
Blood Chemistry test
Measure levels of GPT, GOT, Creatinine, Glycemia, Bilirrubin, Alkaline Phosphatase, LDH in blood.
Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test
Test with the next parameters: if the administration of chemotherapy (CT) and Immunotherapy (IT) treatments will be considered at planned time, number of the cycle administered out of date, days elapsed since the previous cycle and, cause that caused the administration of the CT/IT outside the planned date. In the case of the dose, the medication in which it was modified will be taken into account, as well as the modified dose.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03717298
Brief Title
Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
Official Title
Evaluation of the Effect of Ocoxin-Viusid® Nutritional Supplement in the Life Quality in Patients Diagnosed With Advanced Pancreatic Adenocarcinoma. Phase II
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)
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 investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.
Detailed Description
To assess the effect of Ocoxin-Viusid® on the quality of life of patients with advanced pancreatic adenocarcinoma.
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 advanced pancreatic adenocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Pancreas, Pancreatic Cancer, Advanced Cancer, Digestive System Neoplasms, Pancreatic Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Endocrine System Diseases, Pancreatic Diseases
Keywords
Nutritional supplement, Advanced Pancreatic adenocarcinoma, Ocoxin-Viusid, Oxidative stress, 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
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ocoxin-Viusid
Arm Type
Experimental
Arm Description
It will be used at a rate of 60 ml daily (1 vial every 12 hours).
Intervention Type
Dietary Supplement
Intervention Name(s)
Ocoxin-Viusid®
Intervention Description
An oral solution of Ocoxin-Viusid® (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.
The treatment with Ocoxin-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 from the inclusion of the patient in the study, up to one year.
Primary Outcome Measure Information:
Title
Quality of Life: EORTC QLQ-C30
Description
Life quality measurement through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (ORTC QLQ-C30): an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. It's composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Nutritional Status of the patient during Chemotherapy
Description
Variations in the patient's nutritional status will be considered, measured by body mass Index (a measure of body fat based on height and weight that applies to adult men and women)
Time Frame
12 months
Title
Adverse Events-AE during Chemotherapy Test
Description
A test with the following questions:
Occurrence of an AE in the subject [Yes, No]; Description of the AE [Name of the event]; Duration of the AE [Difference between the start and end date of the event]; Intensity of the AE [According to CTCAE version 4 it will classify in Light, Moderate, Severe, Life-threatening consequences, Death related to AE]; Seriousness of the AE [serious or not serious], Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or sequelae], Causal relationship [According to WHO algorithm it will classify in very probable, probable, possible, improbable, unrelated, not evaluable]
Time Frame
12 months
Title
Hematology test
Description
Levels of Hemoglobin, Platelets, Hemogram with differential in blood extractions.
Time Frame
12 months
Title
Blood Chemistry test
Description
Measure levels of GPT, GOT, Creatinine, Glycemia, Bilirrubin, Alkaline Phosphatase, LDH in blood.
Time Frame
12 months
Title
Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test
Description
Test with the next parameters: if the administration of chemotherapy (CT) and Immunotherapy (IT) treatments will be considered at planned time, number of the cycle administered out of date, days elapsed since the previous cycle and, cause that caused the administration of the CT/IT outside the planned date. In the case of the dose, the medication in which it was modified will be taken into account, as well as the modified dose.
Time Frame
12 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 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 any of the active ingredients of the chemotherapy used
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 30 patients in the study, taking into account 10% of losses.
Facility Information:
Facility Name
"Hermanos Ameijeiras" Surgical Clinical Hospital
City
La Habana
ZIP/Postal Code
10300
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
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