Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer

Catalysis SL

Status and phase: Completed; Phase 2

Conditions: Gonadal Disorders; Neoplasms, Glandular and Epithelial; Genital Neoplasm, Female; Endocrine Gland Neoplasm; Female Urogenital Diseases and Pregnancy Complications; Carcinoma; Endocrine System Diseases; Adnexal Diseases; Female Urogenital Diseases; Ovarian Neoplasm; Urogenital Neoplasms; Genital Diseases, Female; Ovarian Diseases

Treatments: Dietary Supplement: Ocoxin-Viusid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03562897

OOS-CANCER-7

Details and patient eligibility

About

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.

Full 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

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Ocoxin-Viusid®

Experimental group

Description:

Ocoxin-Viusid® before, during and after the Chemotherapy treatment.

Treatment:

Dietary Supplement: Ocoxin-Viusid