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Evaluation Glizigen® and Ocoxin®-Viusid® in High-grade Cervical Intraepithelial Lesions

Primary Purpose

Carcinoma, Neoplasia; Intraepithelial, Cervix, Glandular Neoplasms

Status

Recruiting

Phase

Phase 2

Locations

Cuba

Study Type

Interventional

Intervention

Glizigen® + Ocoxin-Viusid®

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring carcinoma, intraepithelial cervix lesions, Oxidative Stress, Ocoxin Viusid, Glizigen Spray

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients that meet the diagnostic criteria.
Patients with age ≥18 years.
Patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (Criteria from Rio 2011).
Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58).
Patients who give their informed consent to participation in writing.
Patients who consent to perform the conization according to the study schedule.
Patients with normal laboratory parameters within the limits established in the institution (complete blood count, platelets and erythrosedimentation. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.

Exclusion Criteria:

Patients who have received surgical, ablative, radiant, immunomodulatory or chemotherapy treatment 30 days before recruitment.
Patients pregnant or breastfeeding.
Patients with acute cervico-vaginal infections.
Patients with positive serology known to HIV and/or syphilis.
Patients with diseases that compromise the state of consciousness or their possibility of collaboration.
Patients with a history of severe allergic history.
Patients who are participating in another research.

Sites / Locations

Our Lady of Rule No. 52 &/Remedios and Quiroga, LuyanoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Glizigen® spray + Ocoxin-Visuid® oral solution

Outcomes

Primary Outcome Measures

Lesion progression

Colonoscopy. The categories will analyze as: Complete Response-CR (Disappearance of the initial lesion and no new lesions appear). Partial Response-PR (Reduction between 30 to 50% or more of the initial lesion and no new lesions appear). Stable disease-SD (Same morphometry or reduction of less than 30% of the initial lesion). Progressive Disease-PD (Increase in the diameter of the lesion The lesion extends to one or more quadrants that were not in the initial lesion. It will be considered progressive disease when at least two of the response variables are present.The variable viral load will always be present).

Lesion progression

Histology. The categories will analyze as: CR (Disappearance of the initial lesion No degree of Cervical intraepithelial Neoplasia (CIN)). PR (Reduction of CIN to one degree or more). SD (Same degree of initial lesion is maintained). PD (Increase in one degree of the lesion of CIN or presence of histological signs of invasion] It will be considered progressive disease when at least two of the response variables are present. The variable viral load will always be present).

Lesion progression

Virological. The categories will analyze as: CR (Viral genotype- VG: Negative Human Papillomavirus (HPV) detection high or low oncogenic risk and Viral load: Not detectable). PR (VG: No detection of viral genotypes of high oncogenic risk identified in the initial examination, but positive to HPV of low oncogenic risk Viral load: Reduction of the value of the viral load in at least one base logarithm 10). SD (VG: Initial genotypes are maintained Viral load: Equal result than the initial examination, no change in the viral load values). PD (VG: Initial genotypes or appearance of one or more oncogenic genotypes are maintained Viral load: Initial genotypes show an increase in viral load value in at least one base 10 logarithm. Other oncogenic genotypes appear with viral load values greater than or equal to 103 copies / ml.] It will be considered progressive disease when at least two of the response variables are present.The variable viral load will always be present).

Secondary Outcome Measures

Colposcopy response

Complete Response: Disappearance of the initial lesion and no new lesions appear; Partial Response: Reduction between 30 to 50% or more of the initial lesion and no new lesions appear; Stable Disease: Equal morphometry or minor reduction 30% of the initial lesion; Progressive Disease: Increased diameter of the lesion The lesion extends to one or more quadrants that were not in the initial lesion).

Histological Response

Complete Response: Disappearance of initial injury No degree of CIN; Partial Response: Reduction of CIN to one degree or more; Stable Illness: Same degree of initial injury remains; Progressive Disease: Increase by one degree lesion of CIN or presence of histological signs of invasion).

Virological response

Complete response: Viral genotype: Negative result for the detection of human papillomavirus (HPV) with high or low oncogenic risk and Viral load: Not detectable; Partial response: Viral genotype: No detection of viral genotypes of high oncogenic risk (16, 18, 31 , 33, 45, 52 and 58) identified in the initial examination, but positive to HPV of low oncogenic risk and viral load: Reduction of the value of the viral load in at least one logarithm of base 10; Stable Disease: Viral genotype: Se maintain the initial genotypes and viral load: Same result as the initial examination, no change in the viral load values; Progressive Disease: Viral genotype: The initial genotypes are maintained or the appearance of one or more oncogenic genotypes and viral load: genotypes initials show an increase in the viral load value in at least one logarithm of base 10. Other oncogenic genotypes appear with viral load values greater than or equal to 103 copies/ml)

Adverse Events (AE)

The AE will measure as: -Occurrence of an AE in the patient (Yes/No) -Description of the AE (Name of the AE presented) -Duration of the AE (Difference of dates between the start and end of the AE) -Intensity of the AE (Classification according to CECMED Regulation 45/2007 in: Mild, Moderate, and Severe) -Gravity of AE (Serious or Not serious. Considering serious adverse events those that: 1.Produce the patient' death, 2.Life-threatening, 3.Hospitalization or prolongation of hospitalization indicated, 4. Produce significant or persistent disability, 5.Produce birth defect or congenital anomaly) -Attitude respect to the treatment under study (No changes, Dose modification, Temporary interruption of the treatments under study, Definitive interruption of the treatments under study). -Result of the EA (Recovered, improved, persists or sequels) -Causality Relationship (Definitive, Very likely, Probable, Possible, Not related, Unknown)

Full Information

NCT ID

NCT03549273

First Posted

May 25, 2018

Last Updated

July 5, 2022

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT03549273

Brief Title

Evaluation Glizigen® and Ocoxin®-Viusid® in High-grade Cervical Intraepithelial Lesions

Official Title

Evaluation of the Effect of the Combination of the Natural Products Glizigen® and Ocoxin®-Viusid® in the Treatment of High-grade Cervical Intraepithelial Lesions. Phase II

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 11, 2019 (Actual)

Primary Completion Date

December 15, 2022 (Anticipated)

Study Completion Date

June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catalysis SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Phase II clinical trial, monocentric, not controlled, in patients with high grade cervical intraepithelial lesions. A total of 62 patients with a diagnosis of CIN II, III or carcinoma in situ will be included. It is expected that with the combination of natural products Glizigen® and Ocoxin®-Viusid® at least 60% of patients with treated intraepithelial lesions (IEL) have a global response (complete or partial), with elimination of the human papillomavirus and the viral load.

Detailed Description

Main objective: To evaluate the effect of the combination of Glizigen® and Ocoxin®-Viusid® in the treatment of high-grade cervical intraepithelial lesions. Specific objectives: 1. To evaluate the overall response (colposcopic, histological and virological) in patients treated with the combination of the natural products Glizigen® and Ocoxin®-Viusid® in the treatment of high-grade cervical intraepithelial lesions. 2. Evaluate the colposcopic response in patients treated with the combination of natural products. 3. Evaluate the histological response in patients treated with the combination of natural products after conization. 4. Evaluate the virological response in patients treated with the combination of natural products. 5.Describe adverse events during treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Neoplasia; Intraepithelial, Cervix, Glandular Neoplasms, Epithelial Neoplasm, Neoplasms

Keywords

carcinoma, intraepithelial cervix lesions, Oxidative Stress, Ocoxin Viusid, Glizigen Spray

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Glizigen® spray + Ocoxin-Visuid® oral solution

Intervention Type

Dietary Supplement

Intervention Name(s)

Glizigen® + Ocoxin-Viusid®

Intervention Description

Glizigen® spray, topical use, 2 times a day for 6 months with an interruption for 2 months at the end of the third month. Ocoxin®-Viusid® 60 ml daily (1 vial every 12 hours) by oral route for 8 months, preferably administered after breakfast and lunch, without interruption.

Primary Outcome Measure Information:

Title

Lesion progression

Description

Time Frame

9 months

Title

Lesion progression

Description

Time Frame

9 months

Title

Lesion progression

Description

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Colposcopy response

Description

Time Frame

9 months

Title

Histological Response

Description

Time Frame

9 months

Title

Virological response

Description

Time Frame

9 months

Title

Adverse Events (AE)

Description

Time Frame

9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients that meet the diagnostic criteria. Patients with age ≥18 years. Patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (Criteria from Rio 2011). Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58). Patients who give their informed consent to participation in writing. Patients who consent to perform the conization according to the study schedule. Patients with normal laboratory parameters within the limits established in the institution (complete blood count, platelets and erythrosedimentation. In the case of male sex (vasectomy, use of condoms) while the treatment lasts. Exclusion Criteria: Patients who have received surgical, ablative, radiant, immunomodulatory or chemotherapy treatment 30 days before recruitment. Patients pregnant or breastfeeding. Patients with acute cervico-vaginal infections. Patients with positive serology known to HIV and/or syphilis. Patients with diseases that compromise the state of consciousness or their possibility of collaboration. Patients with a history of severe allergic history. Patients who are participating in another research.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Águeda Santana Martínez

Phone

7 690-7225

aguesam@infomed.sld.cu

First Name & Middle Initial & Last Name or Official Title & Degree

ivis Mendoza Hernández

Phone

7 690-7225

ivis@cencec.sld.cu

Facility Information:

Facility Name

Our Lady of Rule No. 52 &/Remedios and Quiroga, Luyano

City

Havana

ZIP/Postal Code

10500

Country

Cuba

Individual Site Status

Recruiting

Facility Contact: