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Completed

NCT Number: NCT03562897

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ocoxin-Viusid

Dietary Supplement

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 outcomes

  1. Quality of life

    Time frame: 4 months

    It will measured by: - EORTC QLQ-C30 (Points of every item and final points)

  2. Quality of life

    Time frame: 4 months

    Karnofsky index (Score of 0-100 points at intervals of 10)

  3. Quality of life

    Time frame: 4 months

    EORTC QLQ-OV28 (Points of every item and final points)

Secondary outcomes

  1. Nutritional State

    Time frame: 4 months

    Body mass index

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 20, 2018
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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