Revisions for Glizigen® and Oncoxin®-Viusid® in cervical intraepithelial lesions of adult women. Phase II | Registro Público Cubano de Ensayos Clínicos

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Glizigen® and Oncoxin®-Viusid® in cervical intraepithelial lesions of adult women. Phase II

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:

Evaluation of the effect of the combination of the natural products Glizigen® and Oncoxin®-Viusid® in the treatment of high-grade cervical intraepithelial lesions ". Phase II

Secondary indentifying numbers:

CAT-2017-4

Issuing authority of the secondary identifying numbers:

National Coordinator Center of Clinical Trials (CENCEC)

Source(s) of monetary or material support:

Laboratorios Catalysis S.L.

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 :

13/02/2018

Reference number:

Not Applicable

Principal investigator

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

First name:

Agueda

Last name:

Santana Martinez

Medical Specialty :

2nd Degree Specialist in Gynecology and Obstetrics

Affiliation:

Maternal and Child Teaching hospital "10 de Octubre"

Postal address:

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

City:

Havana

Country:

Cuba

Zip Code:

10500

Telephone:

+53-76907225

Email address:

aguesam@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:

Maternal and Child Teaching Hospital "10 de Octubre", January 25, 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:

11/05/2018

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:

Cervical intraepithelial lesions

Health condition(s) code:

Cervical Intraepithelial Neoplasia

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms

Intervention(s):

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

Intervention code:

Dietary Supplements

Aerosols

Administration, Oral

Administration, Topical

Intervention keyword:

Oncoxin viusid, Glizigen spray

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):

Global Response (Integrated evaluation of colposcopy, histologic and virological response. Categories: Complete response, Partial response, Stable Disease and Progressive disease). Measurement time: at the fourth month of the patients included and, 9 months (a month after end of treatment). The categories will analyze as: - Complete Response-RC (Colposcopy [Disappearance of the initial lesion and no new lesions appear] Histology [Disappearance of the initial lesion No degree of Cervical intraepithelial Neoplasia (CIN)] Virological [Viral genotype: Negative Human Papillomavirus (HPV) detection high or low oncogenic risk and Viral load: Not detectable]). - Partial Response-RP (Colposcopy [Reduction between 30 to 50% or more of the initial lesion and no new lesions appear] Histology [Reduction of CIN to one degree or more] Virological [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 Viral load: Reduction of the value of the viral load in at least one base logarithm 10] It will be considered partial when at least two of the response variables are present, genotype and viral load variables will always be present). - Stable disease-EE (Colposcopy [Same morphometry or reduction of less than 30% of the initial lesion] Histology [Same degree of initial lesion is maintained] Virology [Viral genotype: Initial genotypes are maintained Viral load: Equal result than the initial examination, no change in the viral load values.] It will be considered a stable disease when at least two of the response variables are present). - Progressive Disease-EP (Colposcopy [Increase in the diameter of the lesion The lesion extends to one or more quadrants that were not in the initial lesion.] Histology [Increase in one degree of the lesion of CIN or presence of histological signs of invasion] Virology [Viral genotype: 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).

Key secondary outcomes:

Related to the response 1- 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). Measurement time: At baseline, at 4 months after starting the treatment and, at 9 months (a month after end of treatment). 2- 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). Measurement time: At baseline, at 4 months after starting the treatment and, at 9 months (a month after end of treatment). 3- 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). Measurement time: At baseline, at 4 months after starting the treatment and, at 9 months (a month after end of treatment). Related to security 4- Adverse Events (AE). Measurement time: At baseline, at 4 months after starting the treatment and, at 9 months (a months after finished the treatment). 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)

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. Patients that meet the diagnostic criteria. 2. Patients with age ≥18 years. 3. Patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (Criteria from Rio 2011). 4. Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58). 5. Patients who give their informed consent to participation in writing. 6. Patients who consent to perform the conization according to the study schedule. 7. Patients with normal laboratory parameters within the limits established in the institution (complete blood count, platelets and erythrosedimentation

Exclusion criteria:

1. Patients who have received surgical, ablative, radiant, immunomodulatory or chemotherapy treatment 30 days before recruitment. 2. Patients pregnant or breastfeeding. 3. Patients with acute cervico-vaginal infections. 4. Patients with positive serology known to HIV and/or syphilis. 5. Patients with diseases that compromise the state of consciousness or their possibility of collaboration. 6. Patients with a history of severe allergic history. 7. Patients who are participating in another research.

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:

62

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:

Ivis

Last Name:

Mendoza Hernandez

Specialty:

Bachelor degree in Pharmaceutical Sciences. Master of Science in Pharmacology

Affiliation:

National Coordinating Center of Clinical Trials (CENCEC)

Postal Address:

5ta A between 60 y 62, Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164227, +53-72164228

Email :

ivis@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:

Agueda

Last Name:

Santana Martinez

Specialty:

2nd Degree Specialist in Gynecology and Obstetrics

Affiliation:

Maternal and Child Teaching hospital "10 de Octubre"

Postal Address:

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

City:

Havana

Country:

Cuba

Zip Code:

10500

Telephone:

+53-76907225

Email :

aguesam@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:

RPCEC00000271

Date of Registration in Primary Registry:

09/05/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

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Glizigen® and Oncoxin®-Viusid® in cervical intraepithelial lesions of adult women. Phase II

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