Back to resultsEvaluation of Ocoxin®-Viusid® in Breast Cancer
Primary Purpose
Breast Cancer, Breast Carcinoma, Adriamycin Toxicity
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
CT + Ocoxin-Viusid
CT + Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, chemotherapy toxicity, Oxidative Stress, Nutritional supplement, Ocoxin Viusid
Eligibility Criteria
Inclusion Criteria:
- Patients who have undergone surgery and histologically confirm a breast carcinoma and who are subject to adjuvant treatment with AC chemotherapy at the time of inclusion in the trial.
- Patients with age ≥18 years of female sex.
- General health status according to the Karnofsky Index ≥ 70.
Laboratory parameters within the normal limits defined to receive this chemotherapy including normal Echocardiogram:
to. Hematopoietic: Hemoglobin ≥ 9 g / L, Total Leukocytes ≥ 3 x 109 cells / L, Neutrophils ≥ 1.5 x 109 cells / L, Platelets ≥ 100 x 109 / L.
b. Hepatic: Liver function within 2.5 times upper normal limit and without liver disease demonstrated by TGP, OGT and alkaline phosphatase.
c. Renal function: creatinine ≤ 132 μmol / l.
- Patients who express written voluntariness to enter the study with their signature of the informed consent document.
- Patients of childbearing age with negative pregnancy test or who have effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.
Exclusion Criteria:
- Patients who have received prior chemotherapy.
- Patients who are receiving another research product.
- Patients with known hypersensitivity to any ingredient of the investigational product.
- Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic diseases and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health or life at risk during your participation in the trial.
- Pregnancy, lactation or puerperium.
- Patients with cerebral metastases and / or leptomeningeal carcinosis.
- Patients with a second concomitant tumor.
- Patients carrying the human immunodeficiency virus (HIV).
Sites / Locations
- National Institute of Oncology and Radiobiology (INOR)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ocoxin-Viusid®
Placebo
Arm Description
The CT with Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + OV nutritional supplement.
The QT Adriamycin scheme 60 mg per m2 of Body Surface (SC) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + a placebo of the OV nutritional supplement.
Outcomes
Primary Outcome Measures
The Ocoxin-Viusid effect in the treatment with chemotherapy
The effect of the treatment will be evaluated from the number of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.
Compliance with the planned chemotherapy schedule
Dichotomous variable that will be evaluated through the answer yes or no. In cases of negative response, the cause of non-compliance will be collected. It will be collected in the evaluation corresponding to each cycle of chemotherapy and in the final evaluation.
The Ocoxin-Viusid effect in the treatment with chemotherapy
The effect of the treatment will be evaluated from the percentage of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.
Secondary Outcome Measures
Evaluation of Quality of Life
It will be measured through the Karnofsky Index. The Karnofsky Index will be collected in each evaluation query (score of 0-100 points at intervals of 10).
Evaluation of Quality of Life
It will be measured through quality of life scale of the EORTC QLQ-C30 (general). It's a questionnaire of 30 questions divided into 3 areas: Functional capacity (physical aspect, social role, cognitive capacity, emotional and social factors; yes or no), symptoms (asthenia, pain and nausea / vomiting; from 1 to 4) and global assessment (from 1 to 10)
Evaluation of Quality of Life
It will be measured through quality of life scale of the EORTC QLQ-BR23 (specific for breast cancer), it contains 31-53 questions, with a scale from 1-4 or 1-7 (bad-excellent):
-Functional scales:
Body image (BRBI) Sexual functioning (BRSEF) Sexual enjoyment (BRSEE) Future perspective (BRFU)
-Symptom scales / items
Systemic therapy side effects (BRST) Breast symptoms (BRBS) Arm symptoms (BRAS) Upset by hair loss (BRHL)
Evaluation of nutritional status
It will be determined through the Body Mass Index (BMI). The investigator must take into account that if the patient presents with ascites, she should indicate a paracentesis (whenever possible and the type of ascites allows it) before measuring her body weight.
Evaluation of nutritional status
It will be determined through the value of total proteins and albumin.
Side effects of the treatment
The safety of the treatment will be determined through the reporting of adverse events that are presented to the research product.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03576521
Brief Title
Evaluation of Ocoxin®-Viusid® in Breast Cancer
Official Title
Efficacy of Ocoxin-Viusid in the Prevention of Acute Toxicity by Chemotherapy in Patients With Breast Cancer. Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 13, 2015 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
February 19, 2018 (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 purpose is to determine the efficacy of the nutritional supplement Ocoxin-Viusid oral solution (OV) in the reduction of acute toxicity of Chemotherapy (CT) treatment with patients with breast carcinoma. A randomized, double-blind phase II clinical trial was designed, with a sample of 120 patients distributed in 2 arms: 60 patients will receive the CT treatment plus the OV, 60 will receive CT plus OV placebo. The OV / placebo will be administered before, during and 3 weeks after the conclusion of the CT. A better tolerance to the treatment is expected with the addition of the nutritional supplement.
Detailed Description
To obtain the sample size, the proportion of patients presenting adverse reactions that require interrupting chemotherapy treatment will be taken into account. In the institution, this figure is close to 15%. Since it is a dietary supplement, with extensive information on the safety of the product, the design is used in a stage of Flemming (without early stop rules). Assuming that the Ocoxin-Viusid product would clearly be declared ineffective (maximal ineffectiveness) if the proportion of patients not presenting adverse reactions was equal to less than 85% (p0), that is the maximum level of success below which the product does not shows signs of efficacy (the study does not guarantee further research) and taking a p1 value of 95%, where p1 is the minimum level of efficacy required from which the product would be declared effective (the results guarantee to continue a study phase III). Assuming an α error of 5% (probability of rejecting the null hypothesis when it is true) and β (probability of rejecting the alternative hypothesis when it is true) of 20% (the power of the test: 1 - β = 80%), It is determined to recruit a maximum number of 59 - 60 subjects. Determine a = 54, where a is the number of responses equal and below which the product is declared ineffective (H0 is accepted). And r = a + 1 is the cut-off point, that is, the number of responses from which the efficacy level ensures to continue to a phase III study. In this case we would expect to obtain a number of successes ≥ 55.
Patients will be randomized after surgery, in the chemotherapy consultation, and once they meet the established inclusion criteria. In order to achieve the masking of the research product, these have been labeled by a balanced randomized list obtained by computer, which will be in the possession of the Biostatistician of the study of the Clinical Investigations Section of INOR and the promoter. The product under study has been consecutively labeled from 1 to 120 (60 patients in each therapeutic arm).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Carcinoma, Adriamycin Toxicity, Cyclosporine Toxicity
Keywords
breast cancer, chemotherapy toxicity, Oxidative Stress, Nutritional supplement, Ocoxin Viusid
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase II randomized, controlled, double blind clinical trial.
Masking
ParticipantCare ProviderInvestigator
Masking Description
A double blind. The masking will be maintained until the analysis of the data. However, access to the code will be allowed if serious adverse events arise related to the research product.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ocoxin-Viusid®
Arm Type
Experimental
Arm Description
The CT with Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + OV nutritional supplement.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The QT Adriamycin scheme 60 mg per m2 of Body Surface (SC) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + a placebo of the OV nutritional supplement.
Intervention Type
Combination Product
Intervention Name(s)
CT + Ocoxin-Viusid
Intervention Description
The included patients received the Ocoxin-Viusid nutritional supplement at a rate of 75 ml daily (25 ml in 3 doses every 8 hours) administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment* and up to three weeks after the end of the treatment.
*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center.
Intervention Type
Combination Product
Intervention Name(s)
CT + Placebo
Intervention Description
The included patients received the OV placebo in oral solution at a rate of 75 ml daily (25 ml in 3 doses every 8 hours), administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment* and up to three weeks after the end of the treatment.
*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center.
Primary Outcome Measure Information:
Title
The Ocoxin-Viusid effect in the treatment with chemotherapy
Description
The effect of the treatment will be evaluated from the number of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.
Time Frame
4 months
Title
Compliance with the planned chemotherapy schedule
Description
Dichotomous variable that will be evaluated through the answer yes or no. In cases of negative response, the cause of non-compliance will be collected. It will be collected in the evaluation corresponding to each cycle of chemotherapy and in the final evaluation.
Time Frame
4 months
Title
The Ocoxin-Viusid effect in the treatment with chemotherapy
Description
The effect of the treatment will be evaluated from the percentage of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Evaluation of Quality of Life
Description
It will be measured through the Karnofsky Index. The Karnofsky Index will be collected in each evaluation query (score of 0-100 points at intervals of 10).
Time Frame
4 months
Title
Evaluation of Quality of Life
Description
It will be measured through quality of life scale of the EORTC QLQ-C30 (general). It's a questionnaire of 30 questions divided into 3 areas: Functional capacity (physical aspect, social role, cognitive capacity, emotional and social factors; yes or no), symptoms (asthenia, pain and nausea / vomiting; from 1 to 4) and global assessment (from 1 to 10)
Time Frame
4 months
Title
Evaluation of Quality of Life
Description
It will be measured through quality of life scale of the EORTC QLQ-BR23 (specific for breast cancer), it contains 31-53 questions, with a scale from 1-4 or 1-7 (bad-excellent):
-Functional scales:
Body image (BRBI) Sexual functioning (BRSEF) Sexual enjoyment (BRSEE) Future perspective (BRFU)
-Symptom scales / items
Systemic therapy side effects (BRST) Breast symptoms (BRBS) Arm symptoms (BRAS) Upset by hair loss (BRHL)
Time Frame
4 months
Title
Evaluation of nutritional status
Description
It will be determined through the Body Mass Index (BMI). The investigator must take into account that if the patient presents with ascites, she should indicate a paracentesis (whenever possible and the type of ascites allows it) before measuring her body weight.
Time Frame
4 months
Title
Evaluation of nutritional status
Description
It will be determined through the value of total proteins and albumin.
Time Frame
4 months
Title
Side effects of the treatment
Description
The safety of the treatment will be determined through the reporting of adverse events that are presented to the research product.
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have undergone surgery and histologically confirm a breast carcinoma and who are subject to adjuvant treatment with AC chemotherapy at the time of inclusion in the trial.
Patients with age ≥18 years of female sex.
General health status according to the Karnofsky Index ≥ 70.
Laboratory parameters within the normal limits defined to receive this chemotherapy including normal Echocardiogram:
to. Hematopoietic: Hemoglobin ≥ 9 g / L, Total Leukocytes ≥ 3 x 109 cells / L, Neutrophils ≥ 1.5 x 109 cells / L, Platelets ≥ 100 x 109 / L.
b. Hepatic: Liver function within 2.5 times upper normal limit and without liver disease demonstrated by TGP, OGT and alkaline phosphatase.
c. Renal function: creatinine ≤ 132 μmol / l.
Patients who express written voluntariness to enter the study with their signature of the informed consent document.
Patients of childbearing age with negative pregnancy test or who have effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.
Exclusion Criteria:
Patients who have received prior chemotherapy.
Patients who are receiving another research product.
Patients with known hypersensitivity to any ingredient of the investigational product.
Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic diseases and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health or life at risk during your participation in the trial.
Pregnancy, lactation or puerperium.
Patients with cerebral metastases and / or leptomeningeal carcinosis.
Patients with a second concomitant tumor.
Patients carrying the human immunodeficiency virus (HIV).
Facility Information:
Facility Name
National Institute of Oncology and Radiobiology (INOR)
City
La Habana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of Ocoxin®-Viusid® in Breast Cancer
We'll reach out to this number within 24 hrs