Back to resultsEvaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
Primary Purpose
Carcinoma, Ovarian Neoplasm, Endocrine Gland Neoplasm
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 Carcinoma focused on measuring Dietary supplements, Ocoxin-Viusid, Nutritional supplement, Ovarian Cancer, Metastasis
Eligibility Criteria
Inclusion Criteria:
- Female patients 18 years of age or older.
- Patients with diagnosis of ovarian epithelial cancer in stages III (not resectable) and IV.
- Patients with general health status according to the Karnofsky Index ≥ 70 (Annex 12).
- Life expectancy equal to or greater than 3 months.
- Patients who give their informed consent in writing to participate in the study.
- Normal functioning of organs and bone marrow defined by the following parameters: -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 -Glycemia values ≤ 10 Umol / L -Values of Creatinine and total bilirubin within the normal limits of the institution. -Values of AST / ALT ≤2.5 times the upper limit of the normal interval established in the institution.
- Patients with a history of cardiovascular disease, with ejection fraction ≥ 55%, measured by echocardiogram.
Exclusion Criteria:
- Patients who are receiving another research product.
- Patients with known hypersensitivity to QT with Carboplatin, Cisplatin and / or Paclitaxel.
- Patients in stage III tributary of surgical treatment at diagnosis.
- Patients with known hypersensitivity to any ingredient of the product research.
- Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver 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, breastfeeding or puerperium.
- Patients with brain metastases and/or leptomeningeal carcinosis.
- Patients' carrier of the human immunodeficiency virus (HIV).
Sites / Locations
- National Institute of Oncology and Radiobiology (INOR)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ocoxin-Viusid®
Arm Description
Ocoxin-Viusid® before, during and after the Chemotherapy treatment.
Outcomes
Primary Outcome Measures
Quality of life
It will measured by: - EORTC QLQ-C30 (Points of every item and final points)
Quality of life
Karnofsky index (Score of 0-100 points at intervals of 10)
Quality of life
EORTC QLQ-OV28 (Points of every item and final points)
Secondary Outcome Measures
Nutritional State
Body mass index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03562897
Brief Title
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
Official Title
Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (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
Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.
Detailed Description
General Objectives -To identify the efficacy of the nutritional supplement Ocoxin-viusid to increase the quality of life of patients with epithelial advanced or metastatic ovarian cancer. Specific Objectives - Identify the influence of the research product on the nutritional status and quality of life of patients. - Describe the toxicity of the research product. - Identify the adverse reactions to the chemotherapy scheme and quantify the interruptions to it by acute toxicity.
Quality of life. It will be measured as: - EORTC Questionnaire QLQ-C30 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - EORTC Questionnaire QLQ-OV28 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at the beginning, in each cycle of QT and 3 weeks after the 3rd cycle of QT
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Ovarian Neoplasm, Endocrine Gland Neoplasm, Urogenital Neoplasms, Ovarian Diseases, Adnexal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Endocrine System Diseases, Gonadal Disorders, Genital Neoplasm, Female, Neoplasms, Glandular and Epithelial
Keywords
Dietary supplements, Ocoxin-Viusid, Nutritional supplement, Ovarian Cancer, Metastasis
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
Arm Description
Ocoxin-Viusid® before, during and after the Chemotherapy treatment.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ocoxin-Viusid
Intervention Description
Ocoxin-Viusid group (Experimental): Oral solution Ocoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will start a week before start Chemotheray treatment (CT) and, It will maintenance until 3 weeks after finished the last cycle of CT (3 cycles of CT of Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel with neoadjuvant intent).
Primary Outcome Measure Information:
Title
Quality of life
Description
It will measured by: - EORTC QLQ-C30 (Points of every item and final points)
Time Frame
4 months
Title
Quality of life
Description
Karnofsky index (Score of 0-100 points at intervals of 10)
Time Frame
4 months
Title
Quality of life
Description
EORTC QLQ-OV28 (Points of every item and final points)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Nutritional State
Description
Body mass index
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients 18 years of age or older.
Patients with diagnosis of ovarian epithelial cancer in stages III (not resectable) and IV.
Patients with general health status according to the Karnofsky Index ≥ 70 (Annex 12).
Life expectancy equal to or greater than 3 months.
Patients who give their informed consent in writing to participate in the study.
Normal functioning of organs and bone marrow defined by the following parameters: -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 -Glycemia values ≤ 10 Umol / L -Values of Creatinine and total bilirubin within the normal limits of the institution. -Values of AST / ALT ≤2.5 times the upper limit of the normal interval established in the institution.
Patients with a history of cardiovascular disease, with ejection fraction ≥ 55%, measured by echocardiogram.
Exclusion Criteria:
Patients who are receiving another research product.
Patients with known hypersensitivity to QT with Carboplatin, Cisplatin and / or Paclitaxel.
Patients in stage III tributary of surgical treatment at diagnosis.
Patients with known hypersensitivity to any ingredient of the product research.
Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver 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, breastfeeding or puerperium.
Patients with brain metastases and/or leptomeningeal carcinosis.
Patients' carrier of the human immunodeficiency virus (HIV).
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
Citations:
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22987944
Citation
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Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
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