Oncoxin-Viusid-Advanced or metastatic ovarian epithelial cancer-Adult women-Phase II

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific 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.

Secondary indentifying numbers:

CAT-2017-2

Issuing authority of the secondary identifying numbers:

National Coordinator Center of Clinical Trials (CENCEC)

Source(s) of monetary or material support:

Catalysis S.L. laboratory Cuban Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

Institute of Nutrition and Hygiene of food(INHA)

Notification date :

21/02/2018

Reference number:

Not applicable

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Karen

Last name:

Lopez Miguel

Medical Specialty :

1st Grade Specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29th street corner. F. Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78388589

Email address:

karenlopez@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

National Institute of Oncology and Radiobiology (INOR), January 4, 2018

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

02/05/2018

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Epithelial advanced or metastatic ovarian cancer

Health condition(s) code:

Carcinoma

Ovarian Neoplasms

Endocrine Gland Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Neoplasms, Glandular and Epithelial

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Endocrine System Diseases

Gonadal Disorders

Intervention(s):

Oncoxin-Viusid group (Experimental): Oral solution Oncoxin-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. Patients will receive 3 cycles of CT (Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel) with neoadjuvant intent.

Intervention code:

Dietary Supplements

Administration, Oral

Intervention keyword:

Oncoxin viusid, Oral Solution

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Quality of life. It will measured by: - EORTC QLQ-C30 (Points of every item and final points). Measurement time: at baseline and, 3 weeks after finished the third CT cycle - EORTC QLQ-OV28 (Points of every item and final points). Measurement time: at baseline and, 3 weeks after finished the third CT cycle - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at baseline, in every CT cycle and, 3 weeks after the third CT cycle

Key secondary outcomes:

1. Nutritional status (Body Max Index calculated by Weight/(Height*Height), the weight expressed in Kg and, the height expressed in meters). Measurement time: at baseline, in every CT cycle and, 3 weeks after the third CT cycle. 2. Compliance with the planned chemotherapy schedule (Yes, No).Measurement time: at baseline, in every CT cycle and, 3 weeks after the third CT cycle. Safety variables 3. Adverse Events- AE. Measurement time: in every CT cycle and, 3 weeks after the third CT cycle. It will measure by: - Occurrence of some AE in the subject (Yes, No). -Type of AE (Description of AE using the Common Terminology Criteria for Adverse Events (CTCAE)-version 4.0) - Intensity of the AE: (Light, Moderate, Severe, Serious that threatens life or incapacitates the subject , Death). - Gravity of the AE (Serious, Not serious) - Duration of the AE (Difference of dates between the start and end of the event) - Attitude regarding the treatment under study (No changes, Dose modification, temporary interruption of the study treatment, Definitive interruption of the study treatment) - Result of the AE (Recovered, Improved, Persisted, Squeals) - Causality relationship (Very probable, Probable, Possible, Improbable, Unrelated, Not evaluable). 4. Laboratory tests (Hemoglobin-g/L, Hematocrit-%, Erythrocyte-109/l, Platelets-109/l, Leukocytes 109/l, Glycemia- mmol/l, Cholesterol-mmol/l, Triglycerides-mmol, Uric acid- µmol/l, Creatinine-mmol/l, Total and direct bilirubin-in μmol/l, Alkaline Phosphatase-U/L, ALT-U/L , AST-U/L, Total proteins- g/l, Albumin-g/l). Measurement time: at baseline, before second and third CT cycle and, 3 weeks after the third CT cycle.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

18 years

Maximum age:

None

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)

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

2

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Roselin

Last Name:

Valle Cabrera

Specialty:

Bachelor in Pharmaceutical Sciences. Master in Clinical Pharmacy. Master in Clinical Trials

Affiliation:

National Coordinator Center of Clinical Trials (CENCEC)

Postal Address:

5th Street A Building CECMED-CENCEC 2nd floor/60 and 62 Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+5372164224

Email :

roselin@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Karen

Last Name:

Lopez Miguel

Specialty:

First Grade Specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal Address:

29th Street, Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+5378388589

Email :

karenlopez@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000269

Date of Registration in Primary Registry:

17/04/2018

Record Verification Date:

2018/04/17

Next update date:

2019/04/17

Link to the spanish version:

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Registered Trials

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Oncoxin-Viusid-Advanced or metastatic ovarian epithelial cancer-Adult women-Phase II

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