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.

Catalysis Laboratory S.L.0 个研究点目标入组 40 人开始时间: 2018年4月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1. Female patients 18 years of age or older.
•2. Patients with diagnosis of ovarian epithelial cancer in stages III (not resectable) and IV.
•3. Patients with general health status according to the Karnofsky Index = 70 (Annex 12)
•4. Life expectancy equal to or greater than 3 months.
•5. Patients who give their informed consent in writing to participate in the study.
•6. 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.
•7. Patients with a history of cardiovascular disease, with ejection fraction = 55%, measured by echocardiogram.

•1. Patients who are receiving another research product.
•2. Patients with known hypersensitivity to QT with Carboplatin, Cisplatin and / or Paclitaxel.
•3. Patients in stage III tributary of surgical treatment at diagnosis.
•4. Patients with known hypersensitivity to any ingredient of the product research.
•5. 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.
•6. Pregnancy, breastfeeding or puerperium.
•7. Patients with brain metastases and/or leptomeningeal carcinosis.
•8. Patients’ carrier of the human immunodeficiency virus (HIV)

发起方

Catalysis Laboratory S.L.