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

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ClinicalTrials.gov Identifier: NCT03562897
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

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

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Ocoxin-Viusid Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Estimated Study Start Date : October 25, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020


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).




Primary Outcome Measures :
  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 Outcome Measures :
  1. Nutritional State [ Time Frame: 4 months ]
    Body mass index



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562897


Contacts
Contact: Roselin Valle Cabrera +53-72164224 roselin@cencec.sld.cu

Locations
Cuba
National Institute of Oncology and Radiobiology (INOR) Not yet recruiting
Havana, Cuba, 10400
Contact: Karen Lopez Miguel, Dr.    +53-78388589    karenlopez@infomed.sld.cu   
Principal Investigator: Karen López Miguel, Dr.         
Sub-Investigator: Yaniurka Cruz Camejo, Dr.         
Sub-Investigator: Laura Selis Pomar, Dr.         
Sub-Investigator: Alejandro Linchenat Lambert, Dr.         
Sub-Investigator: Juan M. Silveira Pablo, Dr.         
Sub-Investigator: Roberto Esperón Noa, Dr.         
Sub-Investigator: Karelia Silvera Candó, BSc         
Sub-Investigator: Vivian Diéguez Rodríguez, BSc         
Sub-Investigator: Zaida Lastres Sosa, BSc         
Sub-Investigator: Idelmis Curbelo Heredia, MSc         
Sub-Investigator: Mircea Betancourt Cabeza, MSc         
Sub-Investigator: Juan J. Lence Anta, Dr.         
Sponsors and Collaborators
Catalysis SL

Publications:

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03562897     History of Changes
Other Study ID Numbers: OOS-CANCER-7
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catalysis SL:
Dietary supplements
Ocoxin-Viusid
Nutritional supplement
Ovarian Cancer
Metastasis

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Pregnancy Complications
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urologic Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Gonadal Disorders
Adnexal Diseases
Neoplasms by Histologic Type
Neoplasms by Site