Cervical intraepithelial lesions
Conditions
Interventions
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®-Vi
Dietary Supplements
Aerosols
Administration, Oral
Oncoxin viusid, Glizigen spray
Sponsors
Laboratorios Catalysis S.L.
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). Measureme | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernandez
National Coordinating Center of Clinical Trials (CENCEC)
Outcome results
None listed