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

July 5, 2022 updated by: Catalysis SL

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
      • Havana, Cuba, 10400
        • National Institute of Oncology and Radiobiology (INOR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ocoxin-Viusid®
Ocoxin-Viusid® before, during and after the Chemotherapy treatment.
Dietary supplement: Ocoxin-Viusid
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 4 months
It will measured by: - EORTC QLQ-C30 (Points of every item and final points)
4 months
Quality of life
Time Frame: 4 months
Karnofsky index (Score of 0-100 points at intervals of 10)
4 months
Quality of life
Time Frame: 4 months
EORTC QLQ-OV28 (Points of every item and final points)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional State
Time Frame: 4 months
Body mass index
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2018

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OOS-CANCER-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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