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

Sponsor

Catalysis SL (Industry)

Overall Status

Completed

CT.gov ID

NCT03562897

Collaborator

(none)

Enrollment

Location

Arm

43.7

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

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.

Actual Study Start Date :

Oct 25, 2018

Actual Primary Completion Date :

Feb 15, 2022

Actual Study Completion Date :

Jun 15, 2022

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Nutritional State [4 months]
Body mass index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).