Clinical trial NCT03562897: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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).

Primary outcomes:
measure: Quality of life
timeFrame: 4 months
measure: Quality of life
timeFrame: 4 months
measure: Quality of life
timeFrame: 4 months
Secondary outcomes:
measure: Nutritional State
timeFrame: 4 months
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: National Institute of Oncology and Radiobiology (INOR)
Study officials:
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